BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAINFRAME 8253001 NIM RESPONSE 3.0

    MDR report key: 3454371 · Received November 7, 2013

    Report

    Report Number
    1045254-2013-00562
    Event Type
    Injury
    Date Received
    November 7, 2013
    Date of Event
    October 3, 2013
    Report Date
    October 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS REPORT ARE THE RESULT OF INFORMATION NOT BEING PROVIDED BY INITIAL REPORTER. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMINANT DEVICES: PATIENT INTERFACE 8253200, RESPONSE, 510K: K083124, SERIAL (B)(4), LOT# 205815448. MANUFACTURE DATE: APRIL 5, 2012 ELECTRODE 8227410 PAIRED 2 CHANNEL, 510K: K990793, PROBE 8225101 5PK STD PRASS FLUSH TIP, 510K: K934426, (B)(4). METHOD: NO TESTING METHODS PERFORMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ¿MONITOR FAILED TO ALARM WHEN NERVE WAS CUT. USING HARMONIC SCALPEL AND PRETESTING WITH HEMOSTAT PINCHING PRIOR TO CUTTING¿THE NIM HAS BEEN USED MULTIPLE TIMES SINCE THIS PRODUCT EVENT AND THE FACILITY HAS HAD NO MORE ISSUES. AT THIS TIME, THE FACILITY DOES NOT PLAN TO RETURN THE DEVICES FOR EVALUATION OR REPAIR.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574552 MAINFRAME 8253001 NIM RESPONSE 3.0 STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC 8253001 205783082

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR