BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALLANT HF

    MDR report key: 17027718 · Received May 30, 2023

    Report

    Report Number
    2017865-2023-21996
    Event Type
    Malfunction
    Date Received
    May 30, 2023
    Report Date
    August 22, 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
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: SECTION D1 BRAND NAME SHOULD BE GALLANT HF INSTEAD OF THE GENERIC ABBOTT ICD. SECTION D2B DEVICE PRODUCT CODE SHOULD BE NIK INSTEAD OF LWS. SECTIONS D4 MODE NUMBER, CATALOG NUMBER, SERIAL NUMBER, LOT NUMBER, EXPIRATION DATE, AND PRIMARY UDI NUMBER SHOULD BE (B)(4) RESPECTIVELY. SECTION D6A DATE OF IMPLANT SHOULD BE (B)(6) 2021 INSTEAD OF UNKNOWN. SECTION G3 PMA/510K NUMBER SHOULD BE P030054 INSTEAD OF UNKNOWN. SECTION H4 DEVICE MANUFACTURE DATE SHOULD BE SEP 29, 2020 INSTEAD OF UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED UNDER SENSING. THE PATIENT CONDITION WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029535 GALLANT HF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CDHFA500Q S000078581 05415067032010

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female