BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPONENT MRI DR

    MDR report key: 20762163 · Received November 22, 2024

    Report

    Report Number
    2124215-2024-73967
    Event Type
    Malfunction
    Date Received
    November 22, 2024
    Date of Event
    November 8, 2024
    Report Date
    November 22, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    PMA / PMN Number
    P150012/S000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE CONCERNS THAT THIS PACEMAKER EXHIBITED PREMATURE BATTERY DEPLETION (PBD). TECHNICAL SERVICES (TS) WAS INITIALLY NOT ABLE TO PROVIDE AN ANALYSIS AS THE LATITUDE STATUS STATED THAT THE COMMUNICATOR WAS NOT CONNECTING AND ADVISED THE REPRESENTATIVE TO TROUBLESHOOT AND NOTIFY THEM WHEN A PATIENT INITIATED INTERROGATION (PII) WAS SENT. SUBSEQUENTLY, A PII WAS SUCCESSFULLY SENT. TS PERFORMED A DATA ANALYSIS AND STATED THAT THE DEVICE WAS PREMATURELY DEPLETING. TS ADVISED DEVICE REPLACEMENT. THE DEVICE REMAINS IN USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2605320 PROPONENT MRI DR IMPLANTABLE PACEMAKER LWP BOSTON SCIENTIFIC CORPORATION L211 328429

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male