BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 3790211 · Received May 5, 2014

    Report

    Report Number
    2124215-2014-07338
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    March 20, 2014
    Report Date
    April 10, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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

    (B)(4). 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

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER BATTERY ALLEGEDLY DEPLETED PREMATURELY. THE DEVICE HAD ONE YEAR REMAINING LONGEVITY WITH A MAGNET RATE OF 90 PPM (PACING PER MINUTE) ABOUT SIX MONTHS AGO. DURING A RECENT FOLLOW UP; HOWEVER, THE LONGEVITY ESTIMATE SHOWED LESS THAN HALF YEAR WITH A MAGNET RATE OF 85 PPM AND WAS ALREADY AT END OF LIFE (EOL). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED TO SUBMIT A MEMORY DOWNLOAD FOR ANALYSIS. THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267664 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1292

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 5076| 1292