BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOGEN MINI ICD VR

    MDR report key: 9105603 · Received September 23, 2019

    Report

    Report Number
    2124215-2019-18935
    Event Type
    Injury
    Date Received
    September 23, 2019
    Date of Event
    September 10, 2019
    Report Date
    February 2, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526533785
    PMA / PMN Number
    P960040/S306
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, AN ENGINEERING-LEVEL LONGEVITY PREDICTION CALCULATION WAS COMPLETED 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. NEXT, A SERIES OF DIAGNOSTIC TESTS WERE CONDUCTED THAT VERIFIED THE PERFORMANCE OF PACING, SENSING, (DEFIBRILLATION), AND RECORDING FUNCTIONS. HAVING MET THE ENGINEERING LONGEVITY PREDICTION, FUNCTIONALLY PASSED 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE BATTERY APPEARED TO BE DEPLETING PREMATURELY AND TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI). SURGICAL INTERVENTION WAS PERFORMED TO EXPLANT DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE BATTERY APPEARED TO BE DEPLETING PREMATURELY AND TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI). SURGICAL INTERVENTION WAS PERFORMED TO EXPLANT DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900619 INOGEN MINI ICD VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION D010 101455 00802526533785

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R