BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 3053299 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04544
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    October 25, 2012
    Report Date
    March 7, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 PATIENT PRESENTED WITH ATRIAL/VENTRICULAR DYSSYNCHRONY. IT WAS DETERMINED THE DEVICE WAS AT END OF LIFE (EOL) BATTER STATUS AND WAS PACING AT VVI 50PPM. IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD THRESHOLDS WERE HIGHER AND THE OUTPUT WAS AT 5 VOLTS. LAST FALL THE REMAINING LONGEVITY WAS PREDICTED AT 1.5 YEARS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT ELECTIVE REPLACEMENT INDICATOR (ERI) WAS LIKELY TRIGGERED SHORTLY AFTER THE LAST FOLLOW-UP DUE TO THE HIGH OUTPUTS WHICH COULD SIGNIFICANTLY REDUCE THE LONGEVITY CALCULATION. THE DEVICE WAS SUCCESSFULLY CHANGED OUT AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157011 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1291

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR 5068| 033-444| 1270| 1291| 330-801| 1254