BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAINFRAME 8253001 NIM RESPONSE 3.0

    MDR report key: 3100144 · Received May 8, 2013

    Report

    Report Number
    1045254-2013-00365
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 17, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURNED FOR EVALUATION (B)(4) 2013. CONCOMITANT DEVICES: 8253200, PATIENT INTERFACE 8253200 RESPONSE 3.0, S/N (B)(4), LOT 205800026 MANUFACTURED: MARCH 30, 2012, 510K: K083124 ETN 8220325, MUTING PROBE 8220325 NIM, 0205813136 MANUFACTURED: APRIL 3, 2012, 510K: K083124 ETN. EVALUATION SUMMARY: THREE DEVICES WERE RETURNED FOR EVALUATION, THE MAINFRAME (8253001), THE INTERFACE (8253200) AND THE MUTING PROBE (8220325). DURING ANALYSIS THE DEVICES WERE TESTED IN ACCORDANCE TO SRI. THE UNIT PASSES ALL ELECTRICAL, FUNCTIONAL AND SAFETY TESTS. THE MAINFRAME WAS TESTED WITH THE INTERFACE CABLE AND A RESISTANCE CHECK WAS PERFORMED ON THE MUTING DETECTOR PROBE. THE VALUES WERE IN RANGE BUT THERE WAS A SMALL CRACK IN THE FERRITE ON THE MUTING PROBE. NO FAULT WAS FOUND WITH ANY OF THE DEVICES.

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER FOR THE PRODUCT IN THIS EVENT HAS BEEN CHANGED TO 1NR3-1383 AND THE LOT NUMBER HAS BEEN CHANGED TO 205715675 DUE TO REVIEW OF PRIOR REPAIR HISTORY AND SALES FOR THIS FACILITY. DEVICE MANUFACTURE DATE IS CONFIRMED TO BE (B)(4), 2012.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). EVALUATION SUMMARY: NO PRODUCT ANALYSIS RESULTS ARE AVAILABLE, USER DID NOT RETURN DEVICE FOR EVALUATION. METHOD: NO TESTING METHODS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CASE WHEN THE DEVICE WAS ON A NERVE, THE NERVE DID NOT RESPOND, THUS THE NERVE WAS CUT. IT IS BELIEVED TO BE A NERVE THAT AFFECTS THE ABILITY TO BLINK. IT WAS CONFIRMED THAT THE DEVICE WAS CHECKED PRIOR TO THE CASE AND PASSED INITIAL SET UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201814 MAINFRAME 8253001 NIM RESPONSE 3.0 STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8253001 205715675

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability