Model Number 100
Event Date 08/27/1999
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Although the pt was receiving a reduction in seizures, she requested the device be removed. She stated that the stimulation "bothered her. " her physician scheduled an appointment to make some adjustments to her device. Subsequently, the pt took some sterile equipment from an area hosp and removed the device at home. The pt was instructed by her neurologist to go to the emergency room. The pt's wound was treated in the emergency room; a drain was put in place, and the wound was stitched.

http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=241087


Model Number 101
Event Date 01/11/2002
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Event Description
Rptr indicated that pt had explanted self. It was reported that the pt went into the restroom and when the pt came out, the generator was out of the pt's chest. The pt opened the healed incision. The pt had apparently pried the generator out with the pt's hands. The pt picked at it until the pt got it out. The pt's lead was explanted by surgeon and the pt was prescribed a prophylactic ten-day dose of amoxicillin. There are no plans for re-implant. Further f/u revealed that the pt was seen in 2002 at which time the pt's staples were removed and the pt was reported to be healing fine from the explant procedure. No further appointments are scheduled.

http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=377618

Pits! Malpractice!

Were these patients misinformed about VNS and driven to self-removal? I had read a few reports were mentally challenged patients had picked at the generator until it emerged through the skin.

The problem with these reports is they are so one-sided and vague with little detail. If we have a hard time deciphering these MAUDE reports, had can the FDA be making sound and ethical decisions based on such sketchy input?

Had they been asking their dr for removal and the doctor just didn't believe them, or were they mental patients. The really sad thing here, I think most of us who have had our VNS removed can really UNDERSTAND why these patients removed their own units. There comes a point where you really can't stand it any longer.

:fear: Ouch, that had to be some excruciating pain there.

What the heck are these docs thinking? What I mean is, if the patient wants the device out, don't push them to what can be the extreme and just take it out.

I have also read about a developmentally disabled person picking their own device out, and wonder if the people in the above MAUDE reports are DD patients. From what I gather from the reports, neither yanked the lead wires/coils out thank goodness.

B)

This one did.


Model Number 300-20
Event Date 07/17/2001
Event Type Injury Patient Outcome Hospitalization;
Event Description
Reporter indicated that patient picked at neck incision site in the pt's sleep and pulled lead off the nerve, out of the generator, and out through the neck incision. The patient's family members discarded the lead. Revision surgery was performed in 2001 and a new lead was implanted.

http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=353517

Oh My God! That was sickening, and then went and had ANOTHER one implanted!

Now which one has a mental problem?
A. Patient proficient in self-removal
B. Surgeon who re-implanted another one
C. Family member who put this patient, someone who appears to not be able to make their own decisions through this ordeal, TWICE

Model Number 302-20
Event Date 11/01/2003
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Event Description
Vns patient had pulled lead wire out from the neck incision. It is not known whether they pulled the lead completely out. The patient has been referred to neurosurgeon for follow-up. The patient has a history of mrsa and had recently experienced a flare up. The patient is reportedly hospitalized for treatment of mrsa.

http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=500547

HOLY $hit! MRSA!! Knowing the #1 side effect of VNS implant is infection. My husband was infected with MRSA at Mike O'Challaghan Federal Hospital VA surgical ward when they amputated his toe and it's been a NIGHTMARE ever since. I can't imagine doing elective surgery with this $hit in your veins and then right after a major flare up. That screams all kinds of wrong to me.

:Yeah That: and : wtf1 :

B)

PS: BB--your post with the A, B, C's of who is mental made me laugh hard outloud! You crack me up! :ROFLMAO:

B)

Model Number 300-20
Event Date 07/01/2007
Event Type Injury Patient Outcome Required Intervention;
Event Description
Reporter indicated that the vns electrodes had been "pulled out" by the patient and that there was an infection at the site of extraction. The ncp generator and lead were explanted as a result of the events. Attempts to obtain additional information from the physician have been unsuccessful to date. Product analysis was completed on the ncp generator and lead, although the electrode portion of the lead was not returned for analysis. No anomalies were identified with the generator or portion of the lead returned.

http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=902907

CYBERONICS, INC. PULSE GEN MODEL 103

Model Number 103
Event Date 05/01/2008
Event Type Injury Patient Outcome Required Intervention;
Event Description
It was reported to manufacturer that shortly after generator replacement surgery, the vns pt opened the chest incision and pulled out the device. Further follow up with the treating physician revealed that the bulky dressing and the "glue" that was used to close the incision following surgery likely bothered the pt. As a result, the pt picked at the site, eventually opening the wound and pulling out the device. The pt has profound mental retardation. Additional info received from the nursing staff at the group home where the pt is cared for, indicated that the pt had picked at the generator incision site after surgery due to irritation from bulky dressing and ended up pulling out the lead. The surgeon then explanted the generator at a later date. At this time, the pt is being evaluated to see if a re-implant will be performed.

http://www.accessdata.fda.gov/scripts/cdrh...FOI__ID=1080753

:D HI Dennis!

I think that is the report I read. I can not believe they would even consider re-implanting this patient. Some people with DD have a high tolerance for pain, so it is no surprise a patient with profound DD will do something that is very painful, but they either don't feel it as pain, or they enjoy pain stimulus.

Take great care!
B)

CYBERONICS, INC. VNS THERAPY PULSE PULSE GENERATOR

Model Number 102
Event Date 01/01/2004
Event Type Injury Patient Outcome Required Intervention;
Event Description
Patient's wound dehisced some time after suture removal following implant surgery. The patient was reportedly seen in hospital emergency room, at which time the wound was "sewn back up. " at recent office visit, treating neurologist indicated that he could not palpate the generator. Review of subsequent chest x-ray revealed that no generator was present in the chest along with no evidence of the lead. Investigation to date has been unable to determine the location of the devices or whether the patient removed the lead and/or generator through the incision sites. The patient's family member has reportedly searched their home for the lead and generator with no success. Repeat x-rays and follow up with neurosurgeon are planned. Investigation to date has been unable to determine the cause of the reported wound dehiscence.


http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=573008

:huh: Makes me wonder if patient was even implanted??? You never know anymore...

B)

Weird!

CYBERONICS, INC. VNS THERAPY PULSE PULSE GENERATOR

Model Number 102
Event Date 08/01/2005
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that the pt is going to have the vns system explanted due to psychosis actions. The pt has reportedly threatened to remove the device themself. The physician reported that the device is currently on. It was also reported that the patient was started to be weaned off of dillantin. It was further reported that the patient did not show for up their recent appointment with the surgeon for a surgery consult.


http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=638454

CYBERONICS, INC. LEAD MODEL 302

Model Number 302-20
Event Date 03/18/2009
Event Type Injury Patient Outcome Required Intervention;
Manufacturer Narrative
Patient physiology caused or contributed to the event.

Event Description
It was reported that the electrodes of a vns patient's lead had begun to extrude through the skin of her right neck. Follow up with the patient's explanting surgeon revealed that the event was believed to be related to the patient being allergic to the material on the electrode. Though the patient has undergone several lead replacement surgeries due to patient manipulation, the patient's surgeon and treating vns therapy physician indicated that there had been no admissions of manipulation for this recent event.

http://www.accessdata.fda.gov/scripts/cdrh...FOI__ID=1397148

CYBERONICS, INC. NCP PULSE GENERATOR

Model Number 101
Event Date 07/01/2002
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
H. 6. Pt picked at incision site, causing it to open.

Event Description
Rptr indicated that pt picked at incision site until it opened. The pt then removed the generator from the pocket. The pt was last seen by physician in 7/02 at which time pt was reportedly healing well. The pt still had their stitches, but there were no signs of infection.

http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=411187

CYBERONICS, INC. PULSE GEN MODEL 102 LYJ

Model Number 102
Event Date 01/17/2006
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Manufacturing records for the pulse generator were reviewed, for sterilization. Manufacturing records for the pulse generator confirmed sterilization of the device prior to distribution. Vns therapy system labeling lists infection as a potential adverse event possibly associated with surgery.

Event Description
Reporter indicated two days post initial implant; infection was noted at the generator site. The patient was prescribed antibiotics. Approximately eight weeks later, signs of infection returned at the generator pocket. Again, antibiotics were prescribed. After the infection cleared, revision surgery was performed to relocate the generator deeper in the chest. Six weeks after surgery, the patient had picked the led out of her body and was holding it in her hands. The physician believes the extrusion event was caused by patient interaction, picking at the lead site. The patient had the generator and lead explanted and is reportedly doing well. Available information suggests that the initial infection was related to the surgical procedure.

http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=760813

CYBERONICS, INC. PULSE GENERATOR

Model Number 102
Event Date 09/01/2007
Event Type Injury Patient Outcome Other;
Event Description
It was reported that a patient became fixated on her vns and tried to "cut it out. " the md reported that he programmed the device off and the patient did get relief from her fixation with the vns. The md confirmed the patient had pre-vns psychiatric issues that were aggravated by the vns. The patient is being referred to a surgeon for explant.

http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=927033

CYBERONICS, INC. BIPOL LEAD MODEL 302

Model Number 302-20
Event Date 05/05/2008
Event Type Injury Patient Outcome Required Intervention;
Event Description
Reporter indicated that vns pt had lead extrusion and infection at the electrode and generator sites. The infection had been present for some time. The infective organism was methicillin-resistant staphylococcus aureus. The pt had previously presented to the emergency room with a deep dehiscence of his cervical incision. The dehiscence resulted from a lanced blister that was a result of tracheostomy tapes near the incision site. The lead extrusion was due to the infection per the reporter. The pt's vns generator and entire lead were explanted. During the surgery, bloody pus and swelling was noted around the generator site, which was indicative of the pt causing self-trauma to the area due to pain. It is not likely the pt will be reimplanted per the reporter. The explanted generator and lead have been returned and are currently in product analysis.

http://www.accessdata.fda.gov/scripts/cdrh...FOI__ID=1057230

CYBERONICS, INC. PULSE GEN MODEL 102

Model Number 102
Event Date 11/30/2007
Event Type Injury Patient Outcome Required Intervention;
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both, the generator and lead prior to distribution.

Event Description
Reporter indicated a vns patient picked at the incision site where the generator was and it began to protrude. The patient's generator became infected and the generator was explanted. The hospital no longer has the generator; therefore, a product analysis will not be performed. The patient will be reimplanted as he did well with vns. Good faith attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh...FOI__ID=1069916

CYBERONICS, INC. NCP PULSE GENERATOR

Event Date 01/01/2001
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that the patient developed an infection and the ncp system was replaced. The original electrodes were left in place on the nerve. The patient developed cyst-like lumps over the incision sites and the second ncp system was removed. Reporter indicated that the patient has gone through 10 surgeries to resolve the infection. Reporter indicated that in december 2001, the patient developed another lump in the scar on their neck which made the scar open, exposing the coil from the nerve. It was reported that the patient's family member pulled the coil out with their fingernails. An attempt to obtain additional information was made. No response to date.

http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=406405

These stories are very disturbing. Why people damage there units baffles me. Some people desire these devices so desperately (especially for TRD) that when they are refused (like a women that I heard about a few years ago) they kill themselves.
For some (maybe not for all) this pulse generator is a life saver. I am one of them!
If a future candidate for this device is too unstable for this procedure. If there is a possibility that this person can not control there impulses, then they should not have this implant!
If medically a physician implants this device improperly then I will repeat what I wrote to MissJennie and that is:

"Whatever doctor installed your device must have been an idiot. My pulse generator and leads were installed in 2005 and I don't suffer the kind of maladies that your describe. My device is at a very high setting (2.25Ma) and the only side effects that I experience are; every five minutes my voice will get hoarse sounding and I will have a little tingling sensation in my chest. I feel no distress in these temporary side effects. I was told to expect them.
The doctor that installed your VNS system must have been incompetent.
Remember, the device can only be turned up to 3Ma. I am almost there so if there were any problems with the design or operation of this device, I would be on the top of the list to feel them and I don't.
I researched all VNS surgeons before I picked the one that I got. If you don't check a doctors background you will more that likely get a hack."

I do not want to see any harm come to Cyberonics and to there "Pulse Generator".
Talking for myself and other suffers, TRD is horrible. This implant plus my Lexapro have been a godsend.

Ditto Patrick!

Labrat, Your the best. :D

Patrick, you are way off base referring to a surgeon as "incompetent" or an "idiot" just because a patient suffered a serious adverse event. The implanting surgeon has nothing to do with the known side effects of the VNS. In your case the device has worked wonders and that is great news but keep in mind that there are thousands of us who have suffered dearly from the device. The VNS nearly killed me and my surgeon was not an "idiot" nor was he "incompetent."

CYBERONICS, INC. VNS THERAPY LEAD BIPOLAR LEAD

Model Number 302-20
Event Date 06/04/2003
Event Type Injury Patient Outcome Hospitalization; Required Intervention

Event Description
Reporter indicated that a portion of pt's lead was protruding from the incision site. Revision surgery was performed during which the exposed portion of the lead was placed back into the pocket. There were no signs of infection. Further follow-up revealed that the pt had picked at the incision site, and had pulled a part of the lead out through the incision. Following the revision surgery, the pt had again picked at the incision site and had again pulled a portion of the lead out through the incision. It was then reported that the pt had a staph infection at the generator site. The pt was seen by a different surgeon who covered the site with tegaderm and treated with bactroban ointment until the pt could be seen by their regular surgeon who was out of town at the time.

http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=468565

CYBERONICS, INC. PULSE GEN MODEL 102

Model Number 102
Event Date 07/28/2009
Event Type Injury Patient Outcome Required Intervention;

Event Description
Reporter indicated a vns therapy pt "decided to remove the battery himself. He literally removed the battery including the leads", and the incision became infected. The physician did not know the pt removed the vns therapy system. The pt's family reports the pt "has been doing strange things", since his medications were changed. Mfr records confirmed device sterility prior to shipment. The explanted vns therapy system has been returned to the mfr and is pending analysis. Good faith attempts to obtain add'l info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh...foi__id=1463630

: surprise : Holy cow! Funny thing is, I can relate to FEELING like I want to rip the damn thing out of my chest but to actually do it is a whole other issue.

:D

Stories like that make me cringe.

B)

CYBERONICS, INC. PULSE GEN MODEL 102

Model Number 102
Event Date 12/31/2008
Event Type Injury Patient Outcome Required Intervention;
Event Description
It was reported that a vns pt was explanted due to an infection that was developed due to pt manipulation. Further info received from the treating neurologist indicated the pt picked at the implant site and pulled the lead out, causing an infection. Furthermore, cultures were taken and the developed infection was reported in the left chest pocket.

http://www.accessdata.fda.gov/scripts/cdrh...foi__id=1487309

I wonder how many of these patients are institutionalized? For someone to pick at it or remove the VNS themselves sounds like someone who needs constant care and is experiencing a high level of discomfort with no one paying any attention or has no way of communicating it. This is so sad and IMHO unnecessary. Quality of life is compromised.

:Yeah That:

B)