BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERFACE 8250200 NIM-RESPONSE

    MDR report key: 1402946 · Received June 12, 2009

    Report

    Report Number
    1045254-2009-00019
    Event Type
    Injury
    Date Received
    June 12, 2009
    Date of Event
    April 30, 2009
    Report Date
    May 19, 2009
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K982595
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDWATCH FORM WAS NOT RECEIVED FROM THE REPORTER, THEREFORE, ANY MISSING OR INCOMPLETE DATA ON FORM 3500A IS THE RESULT OF INFO NOT BEING PROVIDED OR RELEASED BY THE REPORTER DESPITE ATTEMPTS TO OBTAIN THE REQUIRED INFO. REFERENCE ALSO MDR 1045254-2009-00020. AS REPORTED THE FACIAL NERVE WAS CUT, AND THE ENDS OF THE CUT NERVE WERE RECONNECTED DURING SURGERY WITH NO ADD'L F/U CARE REQUIRED AS A RESULT OF THE EVENT. THE PT SUFFERS FROM A LOSS OF MOBILITY IN HALF HER FACE AND THE DOCTORS PREDICT LIGHT MOBILITY WITHIN A YEAR. BOTH THE NIM CONSOLE, AND THE PT INTERFACE WERE RETURNED AND EVALUATED BY THE MEDTRONIC EOC REPAIR DEPT. REPAIR RESULTS ON THE CONSOLE SHOWED IT IS IN GOOD WORKING CONDITION, AND NO ANOMALIES COULD BE FOUND. THE PT INTERFACE WAS EVALUATED AND FOUND TO HAVE EVIDENCE THAT IT WAS TAMPERED WITH. THE CABLE (STRAIN RELIEF) WAS MODIFIED AT INTERFACE END AND WRAPPED WITH BLACK ELECTRICAL TAPE. THE INTERNAL CABLES WERE ALSO ROUTED DIFFERENTLY CRIMPING ONE OF THE WIRES BETWEEN THE LID AND THE HOUSING. THE CUSTOMER ADMITS THEY ARE AT FAULT FOR THE PT EVENT AND TO THE MODIFICATION "MAL-REPAIR" OF THE CABLE AND BOX WHICH CAUSED THE NIM NOT TO REACT, LEADING TO THE CUT NERVE. NO FUNCTIONAL DEVIATIONS COULD BE VERIFIED AS A RESULT OF THE TAMPERING. THERE IS NO REMAINING INVENTORY OF THIS FINISHED GOODS LOT NUMBER. NO ANOMALIES WERE FOUND IN ELECTRONIC OR HARDCOPY MFG DOCUMENTS. WE WILL CONTINUE TO MONITOR AND REPORT TRENDS.

    Description of Event or Problem · 1

    "DURING THE OPERATION, THERE IS A FACIAL NERVE CUTTING BECAUSE OF A PROBLEM WITH THE NIM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERFACE 8250200 NIM-RESPONSE 77ETN ETN MEDTRONIC XOMED, INC. 8250200 2276

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention| S