Guidant Pacemakers built from 1997 - 2000 "May" need replacement !!

[M&M]

Hi, Once again Guidant is in the news.

Guidant warns on 28,000 pacemakers
BusinessWeek - 2 hours ago
JUL. 18 5:16 PM ET Guidant Corp., already under fire for problems with its implantable defibrillators, on Monday warned physicians ...

Guidant Says 28,000 Pacemakers May Need Replacement (Update6)
Bloomberg - 3 hours ago
July 18 (Bloomberg) -- Guidant Corp., the heart-device maker that recalled 100,000 defibrillators last month, said doctors should consider replacing cardiac ...

Guidant issues warning on 28,000 pacemakers
BusinessWeek - 3 hours ago
JUL. 18 3:38 PM ET Guidant Corp. on Monday warned physicians that replacements might be needed for nine pacemaker models made between ...

UPDATE 3-Guidant warns of pacemaker safety problems
Reuters - 5 hours ago
By Susan Kelly. CHICAGO, July 18 (Reuters) - Guidant Corp. (GDT.N: Quote, Profile, Research) said on Monday it is warning doctors ...

Guidant issues warning for 28,000 pacemakers implanted in patients ...
Canada.com, Canada - 6 hours ago
INDIANAPOLIS (CP) - Guidant Corp. warned physicians Monday that replacements might be needed for nine pacemaker models made between ...

Pacemaker warning issued
%0
Globe and Mail, Canada - 7 hours ago
Indianapolis ? Guidant Corp. warned physicians Monday that replacements may be needed for nine pacemaker models made between 1997 ...

Guidant warns about problems with older pacemakers
Minneapolis Star Tribune (subscription), MN - 6 hours ago
Guidant Corp. said Monday it has advised doctors that about 28,000 of its older-generation pacemakers may malfunction and need to be replaced in some patients. ...

Troubles for Guidant Corporation
New York Times, NY - 8 hours ago
Troubles for the Guidant Corporation continued today when the pacemaker manufacturer announced that some of its older implantable heart devices could fail ...

Take Care and Best Wishes to All.
Marilyn

 

[Nancy]

I just looked Joe's model number up, since he has a 2000 model on the potential bad list. So far it looks OK.

This will be the third time he's had a recall scare, first one was Bjork-Shiley (possible strut fractures), second was St. Jude (sylzone ((sp?)) ), and now Guidant. All his car parts are OK, so far.

That's the price you pay for being half human and half machine.

No recalls yet on the Goretex in his back, or his Intraocular implant

 

[Ross]

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Guidant notified physicians and patients of new safety information for
certain models of cardiac pacemakers manufactured between November 25, 1997
and October 26, 2000. A hermetic sealing component used in these devices may
experience a gradual degradation, resulting in a higher than normal moisture
content within the pacemaker case late in the device's service life. The
clinical behaviors associated with this failure mode can result in serious
health complications. Guidant has confirmed twenty reports of loss of pacing
output associated with this failure mode, including five patients
experiencing syncope. Loss of pacing output has also been associated with
reports of presyncope requiring hospitalization. Guidant has received two
reports of sustained Maximum Sensor Rate ("MSR") pacing in which heart
failure may have developed in association with sustained high rate pacing.
Physicians should consider the unique needs of individual patients and the
specific technical recommendations set forth in the July 18, 2005 physician
communication. Guidant recommends that physicians consider replacing devices
for pacemaker-dependent patients and advises patients to seek medical
attention immediately if they notice shortness of breath, dizziness,
lightheadedness or a prolonged fast heart rate.

 

[M&M]

Hi Nancy and Ross, Nancy I'm glad Joe didn't get anyone of the below models. I just found this article from the Guidant website. For anyone who might wonder which device models are in question. Its best to call your doctor if you have one.


Guidant Initiates Worldwide Physician Communications Regarding Important Safety Information and Corrective Action about Certain Pacemakers
Indianapolis, Ind. ? July 18, 2005 ? Guidant Corporation (NYSE: GDT) said today it is voluntarily advising physicians about important safety information regarding certain devices. Guidant apprised FDA of this action, and FDA may classify this action as a recall. This communication advises physicians and their patients of safety information and is intended to limit adverse events. Physicians should use this information to decide how best to treat their patients.

A subset of the following devices manufactured between November 25, 1997 and October 26, 2000 are impacted:

PULSAR® MAX
PULSAR
DISCOVERY®
MERIDIAN®
PULSAR MAX II
DISCOVERY II
VIRTUS PLUS® II
INTELIS II
CONTAK® TR

These products, which are of an earlier generation design, have not been sold or implanted for the last four years.

Guidant has determined that a hermetic sealing component used in the subset of devices listed above may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemaker case late in the device?s service life.

As of July 11, 2005, Guidant has identified sixty-nine (69) devices that may have exhibited this failure mode from approximately 78,000 devices distributed with this component. While no failures have been reported prior to 44 months of service, the likelihood of occurrence increases with implant time. Guidant?s modeling based on field experience and statistical life-table analysis predicts the rate of failure in the remaining active implanted devices to be between 0.17% and 0.51% over the remaining device lifetime. Of the 78,000 devices originally distributed, approximately 28,000 devices remain implanted worldwide; 18,000 of these devices remain in service in the United States with an average implant age of 69 months.

It is Guidant?s recommendation to physicians that they consider the unique needs of individual patients and the specific technical recommendations set forth in Guidant?s physician communication, dated July 18, 2005. In addition, Guidant recommends that physicians consider replacing devices for pacemaker-dependent patients. In addition, Guidant advises patients to seek medical attention immediately if they notice shortness of breath, dizziness, lightheadedness or a prolonged fast heart rate.

The clinical behaviors associated with this failure mode can result in serious health complications. Guidant has confirmed twenty reports of loss of pacing output associated with this failure mode, including five patients experiencing syncope. Loss of pacing output has also been associated with reports of presyncope requiring hospitalization. Additionally, Guidant has received two reports of sustained Maximum Sensor Rate (?MSR?) pacing in which heart failure may have developed in association with sustained high rate pacing. In one report, a patient whose device exhibited sustained MSR pacing was admitted to the hospital with multiple health issues and later died. It is unknown if this device experienced the failure described above as the device was not returned and this failure mode could not be confirmed.

Many of these devices are nearing or have exceeded their estimated longevity and have thus outlived their warranty. Guidant will provide a replacement device at no charge for pacemaker-dependent patients and other patients deemed by their physicians to be best served by replacement, provided the replacement occurs prior to the normal appearance of elective replacement indicators. This supplemental warranty program is available through December 31, 2005. Additionally, Guidant will reimburse patients up to $2,500 for medical expenses remaining after Medicare and/or health insurance coverage, including device replacement or additional follow-up procedures.

?The health and safety of patients is paramount,? stated Ronald W. Dollens, president and CEO, Guidant Corporation. ?Our innovative technologies have saved and improved millions of lives. Guidant works diligently to create the most reliable products and services, enhance patient outcomes, and limit adverse events to patients.?

The actions taken by the company over the last several weeks reflect our commitment to provide more timely information to physicians and patients about our devices. Guidant has worked closely with FDA since the announcement of the physician communications, and has made FDA aware of all Guidant statements set forth in prior press releases, physician communications, and patient letters on this matter. Guidant will continue to work to meet and exceed the expectations of physicians, patients and FDA.

Guidant recently announced its intention to establish an independent panel of experts to recommend guidelines for when to disseminate information to physicians and patients about life-sustaining implantable devices. Guidant plans to cooperate with and enlist the support of other interested parties.

Additional information about this potential issue is available for physicians and patients at 1-866-GUIDANT (1-866-484-3268) (24/7) and http://www.guidant.com/physician_communications/PDM.pdf.

 

[Nancy]

When you go to the Guidant website, you can look up the actual model and the serial number which is on your card. It's very specific.

 

[M&M]

Nancy, Thanks for the information - I didn't know that - when they recalled mine - I called the company and gave them my serial number and they verified that I had the model in question. Perhaps they got so many calls they decided to put the actual serial numbers on their web. I haven't gone on their web for sometime..

Having a class 1 recall is very upsetting. I'm not going to get a replacement - as my battery will be dieing within 6 mos to a year and then I'll get a Medtronic device. Not that they don't have problems with their devices as well - but at least they don't wait three years to tell the patients !!!

Best Wishes
Marilyn