BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERFACE 8250200 NIM-RESPONSE PATIENT

    MDR report key: 1552625 · Received December 4, 2009

    Report

    Report Number
    1045254-2009-00051
    Event Type
    Injury
    Date Received
    December 4, 2009
    Date of Event
    October 22, 2009
    Report Date
    November 5, 2009
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K982595
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT WAS BEING USED FOR TREATMENT. REFERENCE ALSO MEDWATCH NUMBERS 1045254-2009-00052 AND 1045254-2009-00050 FOR THIS EVENT. SPECIFIC PATIENT INFORMATION WAS NOT PROVIDED TO MEDTRONIC AFTER MULTIPLE REQUESTS: SUCH AS; WAS ADDITIONAL TREATMENT REQUIRED, WEIGHT, OUTCOME, AND THE PATIENT'S AGE. THE SURGERY ACTUALLY OCCURRED IN 2009, AND MEDTRONIC WAS NOT NOTIFIED OF THE EVENT UNTIL THE FOLLOWING MONTH. A PRODUCT ANALYSIS WAS PERFORMED BY THE HOSPITAL'S BIOTECH DEPARTMENT AND NO FAULT COULD BE FOUND WITH THE NIM. DESPITE REQUESTS, THE FACILITY HAS NOT BEEN WILLING TO RETURN THE PRODUCT TO MEDTRONIC FOR A PRODUCT ANALYSIS TO DETERMINE IF THE PRODUCT MEETS SPECIFICATION OR CONTRIBUTED TO THE REPORTED INCIDENT. ANNUAL COMPREHENSIVE TESTING AND CALIBRATION BY MEDTRONIC IS RECOMMENDED AT YEARLY INTERVALS. THE NIM HAS BEEN IN THE FIELD FOR OVER 7 YEARS WITHOUT BEING SENT IN FOR SERVICE, CALIBRATION, OR TESTING. THE UNIT HAS BEEN PLACED BACK INTO SERVICE AT THE FACILITY. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. THE USER GUIDE INCLUDES BUT IS NOT LIMITED TO; THE SYSTEM DOES NOT PREVENT THE SURGICAL SEVERING OF NERVES. IF MONITORING IS COMPROMISED, THE SURGICAL PRACTITIONER MUST RELY ON ALTERNATE METHODS, OR SURGICAL SKILL, EXPERIENCE, AND ANATOMICAL KNOWLEDGE TO PREVENT DAMAGE TO NERVES. THE USE OF PARALYZING ANESTHETIC AGENTS WILL SIGNIFICANTLY REDUCE, IF NOT COMPLETELY ELIMINATE, EMG RESPONSE TO DIRECT OR PASSIVE NERVE STIMULATION.

    Description of Event or Problem · 1

    DR WAS PERFORMING A CHOLESTEATOMA TYMPANOMASTOIDECTOMY. ONLY ONE TO TWO SETS OF ELECTRODES PLACED ON THE PATIENT WAS RESPONDING. THE DR STATED THAT THIS WAS ADEQUATE AND COMMENCED WITH THE PROCEDURE. IN A FOLLOW UP DISCUSSION BETWEEN THE OPERATING ROOM STAFF AND THE AREA SALES MANAGER, IT WAS STATED THE NIM SIGNALED WHEN THE FACIAL NERVE WAS DAMAGED AND IT WAS NOT THE NIM'S FAULT. THE FACILITY STAFF INDICATED THAT THE NERVE DID NOT FOLLOW A NORMAL PATH. THE PATIENT WAS TRANSFERRED TO THE FACILITY AND ANOTHER DR FOR ADDITIONAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERFACE 8250200 NIM-RESPONSE PATIENT 77 ETN - ETN MEDTRONIC XOMED, INC. 8250200 25723900

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| O