BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 3904812 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10577
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    July 11, 2013
    Report Date
    April 30, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXPLANTED DEVICE WAS RETURNED TO BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY NINE MONTHS POST-EXPLANT. UPON RECEIPT, 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 SHOWED A REMAINING LONGEVITY OF TWO YEARS IN (B)(6) 2013. AT THE CURRENT DEVICE FOLLOW-UP IN (B)(6) 2013, THE DEVICE WAS AT END OF LIFE (EOL) BATTERY STATUS. IT APPEARED ELECTIVE REPLACEMENT TIME (ERT) WAS DECLARED IN (B)(6) AND EOL IN (B)(6). IT WAS NOTED THAT THE AUTOMATIC CAPTURE FEATURE WAS PROGRAMMED ON AND WAS IN RETRY, RESULTING IN THE RIGHT VENTRICULAR (RV) PACING OUTPUT TO BE SUSPENDED AT 3.5V. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THAT THIS WAS NORMAL DEVICE BEHAVIOR, AND THAT THE AUTOMATIC CAPTURE SUSPENSION LIKELY CONTRIBUTED TO THE BATTERY DEPLETION. DEVICE REPLACEMENT WAS RECOMMENDED. THE DEVICE WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383085 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1292

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR 4087| 1292| 4457