BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALLANT DR

    MDR report key: 21434969 · Received February 21, 2025

    Report

    Report Number
    2938836-2025-00002
    Event Type
    Malfunction
    Date Received
    February 21, 2025
    Date of Event
    January 31, 2025
    Report Date
    May 15, 2025
    Manufacturer
    ST. JUDE MEDICAL INC. (AFD CAT-SUNNYVALE)
    Product Code
    NIK
    UDI-DI
    05415067032003
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1621574 GALLANT DR NO MATCH NIK ST. JUDE MEDICAL INC. (AFD CAT-SUNNYVALE) CDDRA500Q P000168200 05415067032003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male