BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 3040755 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01308
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    December 19, 2012
    Report Date
    February 13, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    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 "GOOD." 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 VARIABILITY IN THE 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THERE WAS CONCERN RELATED TO THIS PACEMAKER'S REPORT OF BATTERY LONGEVITY REMAINING. IN (B)(6) 2012, THE REMAINING LONGEVITY WAS TWO YEARS, THREE MONTHS LATER IT HAD DECREASED TO <0.5 YEARS, AND THEN TWO WEEKS LATER IT WAS BACK UP TO 2.5 YEARS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED POTENTIAL OPTIONS AS TO WHY THIS MIGHT HAVE OCCURRED. ADDITIONALLY IT WAS NOTED THAT THE PATIENT HAD HIGH PACING IMPEDANCES AND NOISE ON THE RIGHT ATRIAL (RA) LEAD. GIVEN THE ISSUES WITH FLUCTUATING BATTERY LONGEVITY IN THIS DEPENDENT PATIENT, AND THE RA LEAD ISSUE, SURGICAL INTERVENTION WAS PERFORMED. THE DEVICE WAS SUCCESSFULLY EXPLANTED AND THE RA LEAD WAS SURGICALLY ABANDONED. A NEW GENERATOR AND LEAD WERE SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142989 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| L| R 1290| 1283| 4261| 0950| 4271