BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 3211161 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07800
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INFORMATION KNOWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT APPROXIMATELY TWO MONTHS POST IMPLANT, FOLLOW UP OF THIS DEVICE REVEALED FOUR AND ONE-HALF YEARS TO END OF LIFE BATTERY STATUS AND THE BATTERY GAUGE HAS SHIFTED TO APPROXIMATELY FORTY PERCENT OF BEGINNING OF LIFE (BOL) STATUS. THERE WAS CONCERN THAT THE BATTERY DEPLETED MORE RAPIDLY THAN EXPECTED. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED. THE APPROXIMATE TIME TO EXPLANT IS THE PROJECT TIME REMAINING UNTIL EXPLANT STATUS IS REACHED AND INFLUENCED BY POWER CONSUMPTION. PROGRAMMING NEW PACING VALUES OR CHANGES IN LEAD MEASUREMENTS WILL IMPACT THE POWER CONSUMPTION AND THE PREDICTED ESTIMATED LONGEVITY. TS ESTIMATED APPROXIMATELY SIX AND SEVEN MONTHS EXPECTED LONGEVITY. A SAVE ALL TO DISK WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IMPLANTED AND IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309568 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND J173

    Patients

    Seq Age Sex Outcome Treatment
    1