BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2171273 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-09795
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    May 31, 2011
    Report Date
    September 14, 2012
    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

    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, ESTIMATED LONGEVITY REMAINING APPEARED TO DEPLETE MORE QUICKLY THAN EXPECTED DURING 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.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. (B)(6) MONTHS LATER, FURTHER INTERROGATION REVEALED THE DEVICE HAS REACHED ELECTIVE REPLACEMENT TIME. (B)(6) MONTHS EARLIER, THE MAGNET RATE WAS 100 AND LONGEVITY EXPECTANCY WAS 1.5 YEARS REMAINING. THERE WAS CONCERN THAT THE BATTERY HAD DEPLETED MORE RAPIDLY THAN EXPECTED. AN INTERNAL TECHNICAL SERVICE WAS CONTACTED. IT WAS SUSPECTED THE SMALL VARIATIONS OBSERVED IN IMPEDANCE AND PACING MAY HAVE CONTRIBUTED TO THE OBSERVATION. A REPLACEMENT PROCEDURE IS INTENDED. THE PATIENT WITH THIS DEVICE IS NOT PACEMAKER DEPENDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. SUBSEQUENTLY, A REPLACEMENT PROCEDURE WAS PERFORMED. THIS DEVICE WAS REMOVED AND REPLACED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, INTERROGATION OF THIS DEVICE REVEALED TWO YEARS BATTERY LONGEVITY REMAINING. TWO MONTHS EARLIER, INTERROGATION REVEALED ONE YEAR REMAINING. NO PROGRAMMING CHANGES WERE MADE. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED REGARDING THE DISCREPANCY. A MEMORY DOWNLOAD WAS PERFORMED AND WAS REVIEWED BY ENGINEERING. IT WAS DETERMINED THIS DEVICE IS FUNCTIONING NORMALLY AND IS NEARING ELECTIVE REPLACEMENT TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1297

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| L| R (B)(4)| (B)(4)| (B)(4)