BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 LESION NT2000 PAIN MANAGEMENT RF GENERATOR

    MDR report key: 12749125 · Received November 3, 2021

    Report

    Report Number
    2184149-2021-00361
    Event Type
    Malfunction
    Date Received
    November 3, 2021
    Report Date
    November 3, 2021
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    GXD
    UDI-DI
    05415067022417
    PMA / PMN Number
    K111576
    Removal / Correction Number
    2184149-04/22/21-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING SERVICE, THERMAL DAMAGE WAS NOTED ON A RF CONTROL BOARD CAPACITOR. THE INVESTIGATION REVEALED THAT THE CAPACITOR ON THE RF CONTROL BOARD FAILED WITHIN TWO YEARS OF SERVICE. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THE PROCESS WAS PERFORMED AND COMPLETED IN ACCORDANCE WITH ABBOTT SPECIFICATIONS AND PROCEDURES.

    Description of Event or Problem · 1

    DURING SERVICE, THERMAL DAMAGE WAS NOTED ON A RF CONTROL BOARD CAPACITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647215 4 LESION NT2000 PAIN MANAGEMENT RF GENERATOR GENERATOR, LESION, RADIOFREQUENCY GXD ST. JUDE MEDICAL, INC. RFG-NT-2000 7248333 05415067022417

    Patients

    Seq Age Sex Outcome Treatment
    1