BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE MRI DR

    MDR report key: 12662491 · Received October 19, 2021

    Report

    Report Number
    2124215-2021-31559
    Event Type
    Injury
    Date Received
    October 19, 2021
    Date of Event
    September 27, 2021
    Report Date
    August 23, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    UDI-DI
    00802526559228
    PMA / PMN Number
    P150012/S000
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY. VISUAL EXAMINATION NOTED NO ABNORMALITIES. THE DEVICE COULD NOT BE INTERROGATED. THE DEVICE CASE WAS REMOVED TO FACILITATE INSPECTION OF THE INTERNAL COMPONENTS AND FURTHER TESTING. THE BATTERY WAS REMOVED FROM THE DEVICE AND REPLACED WITH AN EXTERNAL POWER SOURCE. THE CURRENT DRAIN WAS MEASURED AND FOUND TO BE NORMAL. DETAILED ANALYSIS OF THE BATTERY IDENTIFIED AN INTERNAL SHORT, WHICH WAS CAUSED BY A TEAR IN THE CATHODE INSULATING TUBE. WHICH RESULTED IN THE CLINICALLY-OBSERVED FAULT CODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER REVERTED TO SAFETY CORE MODE. TECHNICAL SERVICES (TS) DISCUSSED DEVICE FUNCTIONALITY AND RECOMMENDED DEVICE REPLACEMENT DUE TO LIMITED THERAPY AVAILABLE IN SAFETY MODE. SURGICAL INTERVENTION WAS UNDERTAKEN. THE PACEMAKER WAS EXPLANTED AND A NEW DEVICE WAS SUCCESSFULLY IMPLANTED. 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 PACEMAKER REVERTED TO SAFETY CORE MODE. TECHNICAL SERVICES (TS) DISCUSSED DEVICE FUNCTIONALITY AND RECOMMENDED DEVICE REPLACEMENT DUE TO LIMITED THERAPY AVAILABLE IN SAFETY MODE. SURGICAL INTERVENTION WAS UNDERTAKEN. THE PACEMAKER 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
    1559933 ACCOLADE MRI DR IMPLANTABLE DEVICE LWP BOSTON SCIENTIFIC CORPORATION L311 385732 00802526559228

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male Life Threatening| H| R