BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2910916 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15549
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 15, 2012
    Report Date
    December 21, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    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. IN ADDITION, ANALYSIS CONCLUDED THIS DEVICE DID NOT EXPERIENCE A COMPONENT MALFUNCTION OR PREMATURE BATTERY DEPLETION, AND REPLACEMENT INDICATORS WERE DISPLAYED APPROPRIATELY RELATIVE TO THE ACTUAL BATTERY CONDITION. HOWEVER, SERVICE LIFE FELL SLIGHTLY SHORT OF LONGEVITY EXPECTATIONS AS OUTLINED IN THE INSTRUCTIONS FOR USE ORIGINALLY APPROVED FOR AND DISTRIBUTED WITH THIS DEVICE. LONGEVITY ESTIMATION TOOLS HAVE SINCE BEEN REFINED TO BETTER REFLECT ACTUAL DEVICE PERFORMANCE AND CURRENT CLINICAL PRACTICES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS DEVICE DISPLAYED END OF LIFE (EOL) BATTERY STATUS. SEVEN MONTHS EARLIER, BATTERY LONGEVITY DISPLAYED WAS ONE AND ONE-HALF YEAR REMAINING AND A MAGNET RATE OF 100 BPM. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED REGARDING EOL BEHAVIOR. THERE WAS CONCERN THAT THE BATTERY DEPLETED MORE RAPIDLY THAN EXPECTED. TS PROVIDED THAT PER LABELING GUIDELINES, DEVICE REPLACEMENT SHOULD BE SCHEDULED WHEN THE DEVICE HAS REACHED ELECTIVE REPLACEMENT INDICATORS (ERI). NO ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, A DECISION WAS MADE TO REPLACE THIS DEVICE. A REPLACEMENT PROCEDURE WAS PERFORMED. THIS DEVICE WAS REMOVED, REPLACED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16946 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 0982

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R