BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® 3.0 MAINFRAME

    MDR report key: 4356127 · Received December 23, 2014

    Report

    Report Number
    1045254-2014-00340
    Event Type
    Malfunction
    Date Received
    December 23, 2014
    Report Date
    December 3, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). CONCOMITANT PRODUCT: 8253200: PATIENT INTERFACE RESPONSE 3.0, SERIAL # (B)(4), LOT # 207443352, MANUFACTURED DATE- (B)(6) 2013. (B)(4). THE MAINFRAME (PART # 8253001) AND PATIENT INTERFACE (PART # 8253200) WERE RETURNED FOR EVALUATION. EVALUATION OF THE MAINFRAME (PART # 8253001) COULD NOT DUPLICATE CUSTOMER'S ISSUE ¿NOT STIMULATING NERVE.¿ EVALUATION FOUND THAT THE UNIT DISPLAY SCREEN WAS UNRESPONSIVE SINCE THE TOUCHSCREEN WAS SCRATCHED, BEZEL GASKET WAS STICKY AND TOUCHSCREEN BOARD VOLUME KNOB WAS LOOSE. EVALUATION ALSO FOUND THAT THE UNIT FAILED SOFTWARE UPGRADE DUE TO DSP BOARD FAILURE. THE UNIT WAS REPAIRED AND TESTED TO SPECIFICATION. EVALUATION OF PATIENT INTERFACE (PART # 8253200) FOUND THAT STIM 1 WAS NOT WORKING DUE TO A BLOWN FUSE. THE BLOWN FUSE WAS REPLACED AND TESTED TO MANUFACTURING SPECIFICATIONS. RESULTS: STRESS PROBLEM. (B)(4). THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS NOT WORKING PROPERLY, IT WAS NOT STIMULATING THE NERVE. THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848007 NIM® 3.0 MAINFRAME STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253001 207457055

    Patients

    Seq Age Sex Outcome Treatment
    1