BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCOLADE MRI DR

    MDR report key: 16766360 · Received April 18, 2023

    Report

    Report Number
    2124215-2023-18477
    Event Type
    Malfunction
    Date Received
    April 18, 2023
    Date of Event
    April 4, 2023
    Report Date
    April 18, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    UDI-DI
    00802526559228
    PMA / PMN Number
    P150012/S000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS DEVICE RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR PROJECTED REMAINING CAPACITY DURING PRE-IMPLANT INTERROGATION DUE TO COLD BATTERY. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REQUIRED PGD FILE. DATA ANALYSIS HAS NOT BEEN COMPLETED; THEREFORE, THIS DEVICE HAS NOT BEEN CLEARED FOR IMPLANT. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1442690 ACCOLADE MRI DR IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION L311 671379 00802526559228

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown