BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 1951986 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23218
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED, ANALYSIS WILL BE PERFORMED AND THIS REPORT WOULD BE UPDATED AT THAT TIME.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED AND RESUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THIS DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION. THE DEVICE MET LABELED LONGEVITY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE PACEMAKER NOTED A LONGEVITY REMAINING OF 2.5 YEARS. THERE IS AN ASSOCIATED ALLEGATION OF PREMATURE BATTERY DEPLETION AGAINST THIS DEVICE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED WHOM CALCULATED AN ESTIMATED LONGEVITY WITH CURRENT PROGRAMMED VALUES; THE ESTIMATED VALUE CORRELATED TO THE LONGEVITY THE DEVICE WAS REPORTING. TS RECOMMENDED PROGRAMMING CHANGES TO EXTEND THE LONGEVITY OF THE DEVICE. CURRENTLY, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR 4087| 4086| S603