Guest Eliza Posted April 12, 2007 Report Share Posted April 12, 2007 I just received this information today and wanted to share it with everyone here because I know there are several people with pacemakers/defibrillators on this site. I hope this is ok to post under "Dysautonomia Discussion" but I felt it definately pertained to it and also wanted to make sure it was read by any one that could be affected. Here is the recall: MedWatch - The FDA Safety Information and Adverse Event Reporting ProgramBoston Scientific/Guidant and FDA informed healthcare professionals andpatients that a subset of devices within the CONTAK RENEWAL 3 & 4,VITALITY and VITALITY 2 families were recalled. The recall includedapproximately 73,000 implantable cardiac defibrillators and cardiacresynchronization therapy defibrillators because of faulty capacitors.The capacitors may cause accelerated battery depletion and may reducethe time between elective replacement indicator and end of life to lessthan three months. Although the current recall is similar to the recallof May 2006, the failure modes and patient outcomes differ from thosedescribed in the May 2006 recall. Patients with one of the recalleddevices should contact their healthcare provider regarding the nextsteps to take.Read the complete 2007 MedWatch 2007 Safety summary, including a link tothe manufacturer's Dear Doctor Letter and the FDA's Q&A documentregarding this issue at:http://www.fda.gov/medwatch/safety/2007/safety07.htm#icd Quote Link to comment Share on other sites More sharing options...
corina Posted April 13, 2007 Report Share Posted April 13, 2007 eliza,although i don't have a pacemaker, i wanted to thank you for posting. as there are several people around here who have one, i think it is important information!corina Quote Link to comment Share on other sites More sharing options...
morgan617 Posted April 13, 2007 Report Share Posted April 13, 2007 I don't have that type, but thanks! I don't keep up with that stuff....I fell and now mine is floating around all over my chest. I got an x ray, but to date (a month?) no one at the cardiology office has looked at it.I have an appt the 23rd and will ask about the recall while I'm there. I think I ripped the sutures loose, that hold down the lead wires.... Quote Link to comment Share on other sites More sharing options...
Dawg Tired Posted April 13, 2007 Report Share Posted April 13, 2007 I have a Guidant Pacemaker but I assume if I am affected I will be hearing from them. At my last visit my battery was at 100% so I'm not worried, and it isn't too long until my regular EP appointment. Quote Link to comment Share on other sites More sharing options...
MightyMouse Posted April 13, 2007 Report Share Posted April 13, 2007 If you check out the Guidant site, you can check your serial number to see if you are among the recalled items.As a general note: pacemakers and defibrilators are frequently among recalled items--battery problems are a known issue among nearly ALL makers. Teri, my spouse, who used to buy these for her hospital, used to get recall notices often. If you are paced or have a combined pacemaker/defibrilator, you should make a habit of checking the FDA's site for recall or warning notices.Nina Quote Link to comment Share on other sites More sharing options...
AJVDK Posted April 13, 2007 Report Share Posted April 13, 2007 Thanks for the post. I have a st. jude pacer. I am hoping it never comes up on the recall list. Also thanks for letting us know. I have not looked for recall since that last big recall about a year ago! Quote Link to comment Share on other sites More sharing options...
taylortotmom Posted April 14, 2007 Report Share Posted April 14, 2007 Thanks for the post. I have an Medtronic- Enrhythm- so safe this time around! Quote Link to comment Share on other sites More sharing options...
MightyMouse Posted April 14, 2007 Report Share Posted April 14, 2007 If you go to the FDA's site using the link given in the first post in this thread, you can find your way through the FDA's site to see if any implants you have (including pacemakers) are on their recall list, warning, etc. This goes for medications too.Nina Quote Link to comment Share on other sites More sharing options...
Guest Eliza Posted April 16, 2007 Report Share Posted April 16, 2007 I am certainly happy to hear that no one here seems to be affected by this recall (yet....keep our fingers crossed). I just felt it was important to post just to be safe. Quote Link to comment Share on other sites More sharing options...
Poohbear Posted April 16, 2007 Report Share Posted April 16, 2007 The FDA also requires the manufacturer to notify YOU if your pacemaker or defib. is under the recall notice. So this is also a reminder to make sure you always have your updated medical card from the company and that you keep them informed of address and phone number changes. Quote Link to comment Share on other sites More sharing options...
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