BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVICE 8252200 NIM-RESPONSE 2.0 INTERFAC

    MDR report key: 2960777 · Received February 14, 2013

    Report

    Report Number
    1045254-2013-00104
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    January 28, 2013
    Manufacturer
    MEDTRONIC XOMED, INC
    Product Code
    ETN
    PMA / PMN Number
    K024316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). NO FAULT FOUND WITH THE UNIT. THE ITEM WAS TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A MALFUNCTION OF CHANNEL 1. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65492 DEVICE 8252200 NIM-RESPONSE 2.0 INTERFAC STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC 8252200 47702000

    Patients

    Seq Age Sex Outcome Treatment
    1