BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALLANT HF

    MDR report key: 19076840 · Received April 9, 2024

    Report

    Report Number
    2017865-2024-38089
    Event Type
    Malfunction
    Date Received
    April 9, 2024
    Date of Event
    March 19, 2024
    Report Date
    July 19, 2024
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NIK
    UDI-DI
    05415067032010
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    NEW INFORMATION RECEIVED NOTES THAT THE PATIENT WAS BROUGHT TO THE CLINIC, AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS PAIRED SUCCESSFULLY. NO PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED BLUETOOTH TELEMETRY LOSS. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. QTD MRI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413205 GALLANT HF NO MATCH NIK ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CDHFA500Q P000138642 05415067032010

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male DURATA MRI| QUARTET| TENDRIL