BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAINFRAME 8252001IPLO LOANER NIM 2.0 IP

    MDR report key: 2994032 · Received March 8, 2013

    Report

    Report Number
    1045254-2013-00240
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    IKN
    PMA / PMN Number
    K024316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE UNIT WAS RETURNED ON (B)(4) 2013 FOR EVALUATION. A COMPLAINT ON THE UNIT WAS NOT IDENTIFIED UNTIL (B)(4) 2013. DEVICE EVALUATION FOUND A LOOSE WIRE ON THE STIM CONTROL CONNECTOR ON THE MUTE DETECTOR BOARD.

    Description of Event or Problem · 1

    A DEVICE WAS RETURNED FOR EVALUATION. THERE WAS NO REPORTED EVENT OR PATIENT IMPACT. DEVICE EVALUATION FOUND A LOOSE WIRE ON THE STIM CONTROL CONNECTOR ON THE MUTE DETECTOR BOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99757 MAINFRAME 8252001IPLO LOANER NIM 2.0 IP ELECTROMYOGRAPH, DIAGNOSTIC IKN MEDTRONIC XOMED, INC. 8252001IPLO 43626000

    Patients

    Seq Age Sex Outcome Treatment
    1