BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2161287 · Received July 13, 2011

    Report

    Report Number
    2124215-2011-06699
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    April 7, 2011
    Report Date
    October 11, 2011
    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, TECHNICIANS USED AN ENGINEERING-LEVEL LONGEVITY PREDICTION CALCULATION TO ASSESS THE RATE OF BATTERY DEPLETION, GIVEN THE PROGRAMMED PARAMETERS AND OTHER DATA STORED WITHIN THE MEMORY OF THE DEVICE. THE RESULTS OF THIS CALCULATION INDICATED THAT THE ACTUAL RATE OF BATTERY DEPLETION FELL WITHIN AN ACCEPTABLE RANGE. BASED ON THE AVAILABLE INFORMATION, IT APPEARED THAT THE DEVICE WAS REPROGRAMMED. THIS REPROGRAMMING CONTRIBUTED TO A SHORTER LONGEVITY REMAINING TO BE CALCULATED DUE TO HIGHER PROGRAMMED SETTING. NEXT, A COMPREHENSIVE SERIES OF DIAGNOSTIC TESTS WERE CONDUCTED THAT VERIFIED THE PERFORMANCE OF THERAPY DELIVERY, SENSING, AND RECORDING FUNCTIONS. HAVING MET THE ENGINEERING LONGEVITY PREDICTION, FUNCTIONALLY PASSING ALL RETURNED PRODUCT TESTING, AND WITH NO FURTHER INFORMATION TO INDICATE A PRODUCT PERFORMANCE ISSUE, WE HAVE CONCLUDED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS THIS DEVICE REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THIS DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE BATTERY GAUGE FOR THIS PACEMAKER SHOWED THE BATTERY WAS HALF FULL, HOWEVER THE CALCULATOR SHOWED LESS THAN HALF A YEAR OF BATTERY LIFE REMAINING. IT WAS ALSO REPORTED THE MAGNET RATE WAS 100. A HEALTH CARE PROFESSIONAL PROVIDED THE PROGRAMMED DEVICE PARAMETERS AND TECHNICAL SERVICES RAN A LONGEVITY CALCULATION. BASED ON THE PROGRAMMED PARAMETERS THE EXPECTED LONGEVITY WOULD BE APPROXIMATELY THREE YEARS. TECHNICAL SERVICES DISCUSSED THE LESS THAN HALF A YEAR LONGEVITY REMAINING WOULD BE MORE ACCURATE THEN THE BATTERY GAUGE. 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 1295

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention 1275| 4504| 7075| 6909| 1295