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To Those With Pacemakers


Guest Eliza
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Guest Eliza

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

Program

Boston Scientific/Guidant and FDA informed healthcare professionals and

patients that a subset of devices within the CONTAK RENEWAL 3 & 4,

VITALITY and VITALITY 2 families were recalled. The recall included

approximately 73,000 implantable cardiac defibrillators and cardiac

resynchronization therapy defibrillators because of faulty capacitors.

The capacitors may cause accelerated battery depletion and may reduce

the time between elective replacement indicator and end of life to less

than three months. Although the current recall is similar to the recall

of May 2006, the failure modes and patient outcomes differ from those

described in the May 2006 recall. Patients with one of the recalled

devices should contact their healthcare provider regarding the next

steps to take.

Read the complete 2007 MedWatch 2007 Safety summary, including a link

to

the manufacturer's Dear Doctor Letter and the FDA's Q&A document

regarding this issue at:

http://www.fda.gov/medwatch/safety/2007/safety07.htm#icd

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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.... :rolleyes:

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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.

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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

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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!

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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

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Guest Eliza

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. :blink:

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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.

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