BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2911410 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15828
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 14, 2012
    Report Date
    November 26, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, DETAILED MECHANICAL AND ELECTRICAL TESTING WAS PERFORMED ON THE DEVICE. THE DEVICE BATTERY STATUS WAS EOL. THE DEVICE FUNCTIONED NORMALLY THROUGHOUT TESTING. LABORATORY ANALYSIS DETERMINED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION; HOWEVER, THE ESTIMATED LONGEVITY REMAINING VALUE APPEARED TO DECREASE MORE QUICKLY THAN EXPECTED BETWEEN ROUTINE FOLLOW-UPS. FACTORS INFLUENCING THE ESTIMATED LONGEVITY REMAINING CALCULATION INCLUDE PACING RATE, AMPLITUDE, PULSE-WIDTH AND LEAD IMPEDANCE. ANY (EVEN SLIGHT) CHANGES IN THESE FACTORS WILL IMPACT THE BATTERY CONSUMPTION CALCULATION AND THEREFORE THE REMAINING LONGEVITY ESTIMATE. PLEASE NOTE THAT, DESPITE THE DROP IN ESTIMATED LONGEVITY REMAINING, THE ACTUAL BATTERY CONDITION DID NOT CHANGE SIGNIFICANTLY BETWEEN FOLLOW-UPS. IN SUMMARY, IT WAS DETERMINED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION, BUT DECLARED EOL EARLIER THAN PREVIOUSLY ESTIMATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER BATTERY STATUS WENT FROM 1.5 YEARS REMAINING AT THE LAST DEVICE CHECK IN (B)(6) 2012 TO END OF LIFE (EOL) IN APPROXIMATELY THREE MONTHS. IT WAS NOTED THAT AT THE LAST DEVICE CHECK THE DEVICE PROGRAMMING HAD BEEN ADJUSTED. NO PATIENT SYMPTOMS WERE REPORTED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED AND DISCUSSED THE CHANGE IN LONGEVITY COULD HAVE BEEN DUE TO THE PROGRAMMING CHANGES (SPECIFICALLY CHANGES IN THE VOLTAGE OUTPUT), HOWEVER A FULL ANALYSIS WOULD HAVE TO BE PERFORMED TO EXPLAIN THE CHANGE IN LONGEVITY. THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16752 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR 432-04-52| 430-10-58| 1270| 1290