Pages: [1]   Go Down
Print
Author Topic: FDA Alert re Medical Device Fragments  (Read 7366 times)
0 Members and 2 Guests are viewing this topic.
gel61820
Moderators
Hero Member
*****

Karma: +2/-0
Offline Offline

Posts: 1013


WWW
« on: September 01, 2008, 03:31:58 AM »

[span style=\'color:blue\']"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:

« Last Edit: September 01, 2008, 04:08:05 AM by Birdbomb » Logged

"Do not go where the path may lead, go instead where there is no path and leave a trail." Ralph Waldo Emerson

VNS implanted July 2007 for Epilepsy.  Activated August 2007.  No success, so VNS was turned off in August 2008 and COMPLETELY removed (including coils) on Nov 25, 2008.
Dispatch
Riding Shotgun
Global Moderators
Hero Member
*****

Karma: +14/-3
Offline Offline

Posts: 2263



« Reply #1 on: September 28, 2008, 02:53:40 AM »

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)
Logged

VNS for TRD implant November, 2006.  Complete device removal including coils April, 2008.

"I reckon it's again my turn to win some or learn some..." Jason Mraz

ALL MY POSTINGS ON THE VNS MESSAGE BOARD ARE NON-TRANSFERABLE
amyclancy
Newbie
*

Karma: +0/-0
Offline Offline

Posts: 12


« Reply #2 on: December 23, 2009, 04:19:51 PM »

so what do you do if you want it removed. is it tosing a coin and hoping for the best. i want this thing out.
Logged
Dispatch
Riding Shotgun
Global Moderators
Hero Member
*****

Karma: +14/-3
Offline Offline

Posts: 2263



« Reply #3 on: December 24, 2009, 03:19:37 AM »

:D Hi Amy!

I have had complete removal.  It was like tossing a coin since the Neurosurgeon could not tell if he could safely remove the coils until he got into my neck and assessed the scar tissue, etc.

For starters, contact the surgeon who put it in and ask tons of questions like: Has he been trained in removal, how many has he removed and how many total explants has he done, will he attempt to at the very least look at the coils around the vagus nerve to assess safe removal, can he provide documentation it is medically necessary for you to have removal (for insurance purposes), what are the chances of vagus nerve damage due to removal, what is recovery time, what will he do if the leads break off in small pieces, can you have the device back, and if that one doesn't want to touch this whole situation, then ask for a referral to a Neurosurgeon who will visit with you.

Take care!
B)

 
Logged

VNS for TRD implant November, 2006.  Complete device removal including coils April, 2008.

"I reckon it's again my turn to win some or learn some..." Jason Mraz

ALL MY POSTINGS ON THE VNS MESSAGE BOARD ARE NON-TRANSFERABLE
Dispatch
Riding Shotgun
Global Moderators
Hero Member
*****

Karma: +14/-3
Offline Offline

Posts: 2263



« Reply #4 on: March 02, 2011, 10:42:42 PM »

 Smiley HEYheyHEY Ya'll!

I though this one needed to be brought back to life since broken leads still haunt me.  Now keep in mind, my leads were recalled and I was never advised, then during removal when the surgeon touched the leads, they broke into little pieces.  The pieces were all taken out, and I've had several x-rays to make sure before I had an MRI.

Be well!
Cool
Logged

VNS for TRD implant November, 2006.  Complete device removal including coils April, 2008.

"I reckon it's again my turn to win some or learn some..." Jason Mraz

ALL MY POSTINGS ON THE VNS MESSAGE BOARD ARE NON-TRANSFERABLE
Pages: [1]   Go Up
Print
Jump to: