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Guidant Pacemaker Problems

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As Many as 28,000 Guidant Pacemakers May Need Replacement

Yael Waknine;

July 19, 2005 ? Guidant Corp. has warned healthcare professionals and consumers via letter that replacements may be needed for nine pacemaker models made between 1997 and 2000, of which approximately 28,000 remain implanted in patients worldwide. The U.S. Food and Drug Administration (FDA) has been apprised of this action and may choose to classify it as a recall.

According to the letter, a hermetic sealing component used in certain pacemakers manufactured between Nov. 25, 1997, and Oct. 26, 2000, may experience gradual degradation, resulting in a higher than normal moisture content within the pacemaker case late in the device's service life.

Affected models include the Pulsar, Pulsar Max (I and II), Discovery (I and II), Meridian, Virtus Plus, Intelis II, and Contak TR. The products are of an earlier generation than those currently available and have not been sold or implanted within the last four years; many of those currently implanted are nearing or have exceeded their estimated longevity (69 months).

Device failure may manifest as one or more malfunctions, including premature battery depletion resulting in loss of telemetry and/or pacing output without warning; inappropriate accelerator function such as sustained pacing at the programmed maximum sensor rate (MSR) or a lack of appropriate rate response during activity; display of a reset warning message on interrogation; and inappropriately early display of replacement indicators.

The company notes that while inappropriate accelerator function has been observed in 60% of pacemaker failures reported to date it is not a reliable early indicator of failure mode. Currently, there are no tests available to predict the risk of failure for any particular device.

The company has identified 69 pacemaker failures worldwide thus far, all of which occurred at least 44 months postimplantation. Devices still in use are estimated to have a failure rate of 0.17% to 0.51% for their remaining service life.

The failures include 20 reports of pacing loss, some of which resulted in syncope (five patients) and presyncope requiring hospitalization. Sustained MSR pacing has been linked to heart failure in two patients.

Guidant recommends that physicians consider replacing devices for pacemaker-dependent patients. Patients with implanted devices should be advised to seek immediate medical attention if they develop a prolonged rapid heart rate, experience syncope or lightheadedness, or have new/increased symptoms of heart failure.

When selecting an MSR setting, physicians should consider the potential for inappropriate sustained pacing at that level. The accelerometer function may be turned off to prevent sustained MSR pacing, though this will not prevent the occurrence of other failures.

An increased frequency of programmer follow-ups is recommended to detect failures that may have already occurred. Physicians should also consider increasing the frequency of transtelephonic monitoring to detect inappropriate sustained MSR pacing and/or loss of pacing output.

At each patient follow-up, the pacemaker should be evaluated for clinical malfunction, signs of early or rapid battery depletion, and inappropriate accelerometer rate responses in devices using the function.

Physicians should be vigilant and look for inappropriate MSR pacing or pacing higher than the lower rate limit when the patient is at rest and a lack of pacing response to physical activity (isometrics, short hall walk). Accelerometers set at "OFF" should be temporarily set to "ON" for evaluation.

Guidant will be providing replacement devices at no charge through the end of the year, irrespective of warranty expiration dates. In addition, patients will be reimbursed up to $2,500 for medical expenses remaining after Medicare and/or healthcare insurance coverage to cover device replacement or additional follow-up procedures.

Further information regarding use of the pacemakers may be obtained by contacting a local Guidant representative or Guidant Technical Services at 1-800-CARDIAC (1-800-227-3422).

Adverse events related to their use should be reported to the FDA's MedWatch program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

Reviewed by Gary D. Vogin, MD

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