BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 3213659 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08200
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    March 9, 2013
    Report Date
    May 16, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 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 THE PACEMAKER HAD REACHED END OF LIFE (EOL). A FEW MONTHS AGO, THE BATTERY SHOWED ONE YEAR REMAINING IN LONGEVITY AND THE MAGNET RATE WAS 90 PULSES PER MINUTE (PPM). AUTOCAPTURE WAS ALSO OFF AND THE OUTPUTS WERE A LITTLE HIGHER THAN NORMAL. THE PATIENT ALSO REPORTED FEELING TIRED ALL OF THE TIME. THE DEVICE WAS EVENTUALLY EXPLANTED FOR NORMAL BATTERY DEPLETION AND WAS SENT BACK FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312059 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR 4087| 1290| 4088