BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERFACE 8252800 RESPONSE 2.0 INCREMENT

    MDR report key: 2981601 · Received February 27, 2013

    Report

    Report Number
    1045254-2013-00166
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Report Date
    January 31, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K024316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND REPAIR. ANALYSIS CONFIRMED THE ALLEGED COMPLAINT AND FOUND FAILURE IN THE PATIENT INTERFACE BOARD, WHICH WAS REPLACED. DUE TO THE AGE OF THE DEVICE BEING LESS THAN 1 YEAR AT THE TIME OF REPAIR AND THE USAGE ENVIRONMENT OF THE PATIENT INTERFACE, THE MOST LIKELY CAUSE OF THE CIRCUIT BOARD MALFUNCTION IS CONSIDERED TO BE MISUSE/MISHANDLING BASED ON THE POTENTIAL DAMAGE IT CAN INCUR DURING USE FROM DROPPING, ETC. THE DEVICE WAS REPAIRED, TESTED TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CERTAIN CHANNELS ON THE NIM RESPONSE 2.0 INCREMENTING PATIENT INTERFACE WERE NOT RESPONDING PREOPERATIVELY. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84191 INTERFACE 8252800 RESPONSE 2.0 INCREMENT STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8252800 205796940

    Patients

    Seq Age Sex Outcome Treatment
    1