BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALLANT HF

    MDR report key: 21890401 · Received April 23, 2025

    Report

    Report Number
    2017865-2025-50898
    Event Type
    Malfunction
    Date Received
    April 23, 2025
    Report Date
    May 7, 2025
    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
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF A LOSS OF BLE TELEMETRY WAS CONFIRMED. BASED ON THE INFORMATION PROVIDED, IT WAS CONFIRMED THAT THE BLE WAS DISABLED DUE TO A DEVICE ANOMALY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED BLUETOOTH (BLE) TELEMETRY LOSS. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATED THE ICD WAS IN JUNO ONLY MODE (JOM) AND WAS RECOVERED SUCCESSFULLY USING THE RECOVERY PROTOCOL. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1291608 GALLANT HF NO MATCH NIK ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CDHFA500Q S000078612 05415067032010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female