BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® 3.0 INTERFACE

    MDR report key: 6206477 · Received December 27, 2016

    Report

    Report Number
    1045254-2016-00436
    Event Type
    Malfunction
    Date Received
    December 27, 2016
    Report Date
    November 28, 2016
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    UDI-DI
    00643169283275
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF REPORT: 11/28/2016. DESCRIBE EVENT PROBLEM: ADDITIONAL INFORMATION RECEIVED STATING THAT THE SYSTEM WAS "NOT RESPONDING WHEN STIMULATING AREAS THAT "SHOULD" HAVE NERVES". THERE WAS NO PATIENT IMPACT. EMAIL: (B)(6). DATE MANUFACTURER RECEIVED: 01/25/2017. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: 8253002: NIM MAINFRAME RESPONSE 3.0, SERIAL # (B)(4), LOT # 208955668, MANUFACTURED DATE ¿NOV/17/2014, 510(K) # K083124, (B)(4). THE NIM PATIENT INTERFACE (PRODUCT # 8253200) AND THE NIM MAINFRAME (PRODUCT # 8253002) WERE RETURNED FOR EVALUATION. EVALUATION OF PATIENT INTERFACE (PRODUCT # 8253200) FOUND THAT THE WAVE SPRING WASHERS WERE WORN. THE DEVICE WAS REPAIRED, TESTED TO MANUFACTURER PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER. EVALUATION OF THE NIM MAINFRAME (PRODUCT # 8253002) CONFIRMED THE CUSTOMER'S ISSUE OF NOT WORKING WELL. DURING INSPECTION THE DEVICE HAD A START UP ALARM FAILURE. THE AUDIO PCB ON THE DEVICE FAILED. THE DEVICE WAS REPAIRED, TESTED TO MANUFACTURER PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED STATING THAT THE SYSTEM WAS "NOT RESPONDING WHEN STIMULATING AREAS THAT "SHOULD" HAVE NERVES". THERE WAS NO PATIENT IMPACT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NIM SYSTEM IS STILL NOT WORKING WELL AFTER BEING RETURNED FROM REPAIR RECENTLY. THERE WAS NO REPORT OF PATIENT IMPACT. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FOR THIS REPORTED EVENT HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857365 NIM® 3.0 INTERFACE STIMULATOR, NERVE GWF MEDTRONIC XOMED INC. 8253200 208928940 00643169283275

    Patients

    Seq Age Sex Outcome Treatment
    1