BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALITUDE CRT-P

    MDR report key: 16985348 · Received May 23, 2023

    Report

    Report Number
    2124215-2023-25655
    Event Type
    Malfunction
    Date Received
    May 23, 2023
    Date of Event
    May 2, 2023
    Report Date
    May 23, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NKE
    UDI-DI
    00802526559389
    PMA / PMN Number
    P030005/S113
    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 CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) RECORDED A CODE 1003 AT PRE-IMPLANT WHICH AN INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) OFFERED TO SEND IN A PRETTY GOOD PRIVACY (PGD) FILE, HOWEVER, FIELD REPRESENTATIVE DID NOT HAVE THE ABILITY TO SEND IN A PGD FILE AND WAS IN SEARCH FOR ANOTHER DEVICE TO USE FOR THE CASE AS FIELD REPRESENTATIVE WAS IN THE MIDDLE OF THE CASE. AS OF THIS TIME, THIS DEVICE WAS NOT IN SERVICE. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1410203 VALITUDE CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) NKE BOSTON SCIENTIFIC CORPORATION U125 721088 00802526559389

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown