ALTRUA 20
Models S201/S206/S208/S209
ALTRUA 40
Models S403/S404
ALTRUA 50
Models S503/S504/S508
ALTRUA 60
Models S601/S602/S603/S606
Voluntary Physician Advisory — Canada Only
This advisory is limited to ALTRUA pacemakers distributed in Canada. No geographies other than Canada are affected by this advisory.
Boston Scientific has determined that approximately 400 ALTRUA devices were distributed in Canada with Lead Configuration programmed to a factory nominal value of unipolar even though package labeling and Instructions for Use state that the nominal value is bipolar.
The ALTRUA pacemaker models listed on the left include a programmable parameter referred to as “Lead Configuration.” This feature allows clinicians to program the device to match the type of lead implanted in the patient — either unipolar or bipolar. Because the type of lead preferred by physicians varies by geography, the factory nominal value for this parameter also varies by geography. In January 2010, ALTRUA box labels, the Physician Technical Manual, and the System Guide for Canada were updated to reflect a proposed change in the nominal value for Lead Configuration from unipolar to bipolar. However, the actual nominal setting in the device remained factory preset to a value of unipolar. The device functions as intended, and Lead Configuration can be reprogrammed to bipolar if clinically indicated.
Clinical Implications
Unlike bipolar pacemakers, which will begin pacing immediately upon lead connection, the titanium case of a pacemaker programmed to unipolarbecomes electrically active and must be positioned within the implant pocket to begin pacing.For this reason, if a physician attempts to implant a device that he/she thinks is configured to bipolar but is actually programmed to unipolar, the system will not begin pacing until the device case makes contact with patient tissue. If not diagnosed quickly, any potential confusion created by this mismatch between factory setting and labeling could result in a delay to the initiation of pacing. Although this mismatch is primarily a concern during the implant procedure, it is possible that an implanted pacing system may be operating with a lead configuration that is different than the physician intended.
One clinical event has been reported to Boston Scientific. The patient experienced a short delay in initiation of pacing during the implant procedure. This was resolved without a prolonged asystolic pause or patient harm by quickly placing the titanium case in the body to begin pacing.
Reported events (worldwide)
One report has been received of a short delay in initiation of pacing during the implant procedure. Pacing was established by quickly placing the titanium case in the body.
There have been no reported patient deaths associated with this advisory.
Prior to implanting affected ALTRUA pacemakers, interrogate each device and use programmer screens (rather than device labeling) to confirm current lead configuration values. As recommended in labeling, reprogram the device as needed to ensure that lead configuration and all other programmable values match the patient's needs.
If an affected device has already been implanted, consider reevaluating the programmed setting for lead configuration at the next scheduled follow-up visit, and reprogram if indicated.
Standard Warranty program available, please contact your local representative for terms and conditions.
With respect to the number of reported events listed in the summaries above, Boston Scientific recognizes that the actual number of clinical malfunctions may be greater than the number actually reported. Additionally, rate projections are provided with the acknowledgement that predictive modeling is inherently uncertain due to its dependence on the device age distribution of reported events and resultant statistical approximation and assumptions.
Advisory notifications may vary by geography, based upon local regulatory requirements. Please contact the local Boston Scientific office for more information. Not all products may be approved for use in all geographies, as product approval is geography specific.
