"This story originally aired in January 2008. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern.

A recent FDA article in the journal Nursing2007 alerts healthcare personnel about the potential dangers posed by fragments of medical devices that are left in a patient's body. FDA receives more than a thousand reports each year of device fragments breaking off during invasive procedures or from devices already implanted in the body. The fragments may have been left in the body because they could not be retrieved or because the risk of removing them was greater than the risk of leaving them in place.

Many of these reports involve fragments of catheters and guidewires that are left in the patient's body, and some have caused death. In one case, a patient died from cardiac tamponade after a fractured guide wire lodged in a coronary artery and could not be removed.

The article also points out that metallic fragments in the patient's body can move or become heated during MRI exams, and if the fragment is near a vital organ or blood vessel, this can cause injury.

Several dangerous techniques can increase the likelihood of device breakage, such as using too much force during insertion or withdrawal, bending a device to conform to the patient's anatomy, and using old or worn devices.

The article lists several steps healthcare personnel can take to minimize the risks associated with unretrieved device fragments. Here are some of them:

• Make sure that the presence of the fragments is noted in the patient's record.

• Let patients know about any device fragments they may have, and instruct them to report this to other caregivers in order to avoid future complications during testing or treatment.

• When treating a patient, ask about a history of unretrieved device fragments.


Additional Information:

Fischer, Robert A. Danger: Beware of Unretrieved Device Fragments. Nursing2007 - November. Volume 37, Issue 11, p. 17.
http://www.fda.gov/cdrh/medicaldevicesafet...ticles/udf.html

Epidural Conduction Device Fractures and Complications of Retained Fragments. Journal of the American Association of Nurse Anesthetists. February 2008, Vol. 76, No. 1.
http://www.fda.gov/cdrh/medicaldevicesafet...s/epidural.html

FDA Public Health Notification. Unretrieved Device Fragments. January 15, 2008.
http://www.fda.gov/cdrh/safety/011508-udf.html"

FDA Alert - Fragments of Medical Devices Left Inside of Patients Bodies

If the entire VNS (stimulator, leads AND coils) is not removed during explantation, there could be other problems than not being able to get any MRI.

If you are a patient who has had complete removal and know the leads broke during explant, it would be a good idea to tell your Physicians, diagnostic facilities, and treating facilities (for CAT scans, MRI's, theraputic ultrasound, diathermy, etc.) that the leads broke apart during explant. Although the surgeon feels he/she got all the fragments out, there could be a possible oversight and problems if there is a tiny piece in there.

Actually, in my opinion, it would be wise to tell ALL of your caregivers about implant and explant whether complications or not so special precautions are taken. It is better to error on the side of caution versus problems that could chance your life.

Dispatch B)