BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALLANT HF

    MDR report key: 21687012 · Received March 25, 2025

    Report

    Report Number
    2938836-2025-00003
    Event Type
    Malfunction
    Date Received
    March 25, 2025
    Date of Event
    March 3, 2025
    Report Date
    May 15, 2025
    Manufacturer
    ST. JUDE MEDICAL INC. (AFD CAT-SUNNYVALE)
    Product Code
    NIK
    UDI-DI
    05415067032010
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL IS TO REPORT A CHANGE OF FDA REGISTRATION MANUFACTURING SITE INFORMATION FROM ST. JUDE MEDICAL INC. (AFD CAT-SUNNYVALE) 2938836 TO ST. JUDE MEDICAL, INC. (CRM-SYLMAR) 2017865.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED BLUETOOTH (BLE) TELEMETRY LOSS. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATED THE BLE ISSUE WAS DUE TO THE PATIENT'S CELL PHONE AND WAS RESOLVED GIVING THE PATIENT A NEW MOBILE TRANSMITTER (MTX). THERE WERE NO REPORTED PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114077 GALLANT HF NO MATCH NIK ST. JUDE MEDICAL INC. (AFD CAT-SUNNYVALE) CDHFA500Q A000158540 05415067032010

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female