BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNAGEN EL ICD DR

    MDR report key: 12628255 · Received October 13, 2021

    Report

    Report Number
    2124215-2021-27120
    Event Type
    Injury
    Date Received
    October 13, 2021
    Date of Event
    August 16, 2021
    Report Date
    June 16, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526534324
    PMA / PMN Number
    P960040/S306
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. INTERROGATION OF THE DEVICE CONFIRMED IT WAS OPERATING IN SAFETY MODE AND THAT BOTH BRADY AND TACHY THERAPY REMAINED AVAILABLE. REVIEW OF DEVICE MEMORY IDENTIFIED AN ERROR. THE ERROR RESULTED IN SOFTWARE RESETS PERFORMED IN AN ATTEMPT TO CORRECT AN IDENTIFIED MEMORY INCONSISTENCY. THE CORRUPTED MEMORY WAS CORRECTED IN THE LABORATORY AND THE DEVICE REVERTED TO NORMAL OPERATION. THE CAUSE OF THE MEMORY INCONSISTENCY WAS NOT ABLE TO BE DETERMINED THROUGH LABORATORY TESTING BUT WAS LIKELY THE RESULT OF EXPOSURE TO RADIATION, EITHER THERAPEUTIC OR ENVIRONMENTAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REVERTED TO SAFETY CORE MODE UNEXPECTEDLY. TECHNICAL SERVICES (TS) DISCUSSED DEVICE FUNCTIONALITY AND RECOMMENDED DEVICE REPLACEMENT DUE TO LIMITED THERAPY AVAILABLE IN SAFETY MODE. SURGICAL INTERVENTION WAS UNDERTAKEN. THE ICD WAS EXPLANTED AND REPLACED WITH A NEW DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED WITH PERTINENT INFORMATION, UPON COMPLETION OF PRODUCT ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REVERTED TO SAFETY CORE MODE UNEXPECTEDLY. TECHNICAL SERVICES (TS) DISCUSSED DEVICE FUNCTIONALITY AND RECOMMENDED DEVICE REPLACEMENT DUE TO LIMITED THERAPY AVAILABLE IN SAFETY MODE. SURGICAL INTERVENTION WAS UNDERTAKEN. THE ICD WAS EXPLANTED AND REPLACED WITH A NEW DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED WITH PERTINENT INFORMATION, UPON COMPLETION OF PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1524037 DYNAGEN EL ICD DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION D152 575950 00802526534324

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Hospitalization| R