BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URGENT PC NEUROMODULATION SYSTEM LEAD SET

    MDR report key: 12466867 · Received September 13, 2021

    Report

    Report Number
    MW5103878
    Event Type
    Malfunction
    Date Received
    September 13, 2021
    Date of Event
    July 19, 2021
    Report Date
    September 9, 2021
    Manufacturer
    LABORIE MEDICAL TECHNOLOGIES
    Product Code
    NAM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN APPLYING THE URGENT PC DEVICE TO THE PATIENT'S PTNS NEEDLE IN HER ANKLE THE URGENT PC DEVICE ONLY ALLOWED THE USER TO GO UP TO LEVEL 4 AND THEN TURNED OFF AUTOMATICALLY. DEVICE WAS PLUGGED IN AND BOTH LEADS DID THE SAME THING. WHEN SWITCHED TO AN ENTIRELY DIFFERENT LEAD, IT WORKED COMPLETELY FINE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360770 URGENT PC NEUROMODULATION SYSTEM LEAD SET STIMULATOR, PERIPHERAL NERVE, NON-IMPLANTED, FOR PELVIC FLOOR DYSFUNCTION NAM LABORIE MEDICAL TECHNOLOGIES REF UPC 250-12 104641

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR