BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® 3.0 MAINFRAME

    MDR report key: 6646094 · Received June 16, 2017

    Report

    Report Number
    1045254-2017-00190
    Event Type
    Malfunction
    Date Received
    June 16, 2017
    Report Date
    May 22, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    UDI-DI
    00643169230385
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT(S): A 8253200: NIM PATIENT INTERFACE RESPONSE 3.0, SERIAL # (B)(4), LOT # 210021763, MANUFACTURED DATE ¿ AUG/20/2015, 510(K) # K083124, UDI # (B)(4). A 8220325: NIM MUTING PROBE, UNKNOWN LOT NUMBER, UNKNOWN MANUFACTURED DATE, 510(K) # K083124. THE NIM MAINFRAME (PRODUCT # 8253001), NIM PATIENT INTERFACE (PRODUCT # 8253200) AND THE NIM MUTING PROBE (PRODUCT # 8220325) WERE RETURNED FOR EVALUATION. EVALUATION OF THE NIM MAINFRAME (PRODUCT # 8253001) COULD NOT DUPLICATE CUSTOMER'S ISSUE OF NOT WORKING PROPERLY. EVALUATION FOUND NO FAULT WITH THE DEVICE. AS A PRECAUTIONARY MEASURE THE DEVICE WAS PLACED IN THE BURN IN FOR 24 HOURS TO OBSERVE ANY FAILURES, THE UNIT NEVER FAILED. THE DEVICE TESTED TO MANUFACTURER PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER. EVALUATION OF PATIENT INTERFACE (PRODUCT # 8253200) COULD NOT DUPLICATE CUSTOMER'S ISSUE OF NOT WORKING PROPERLY. EVALUATION FOUND THAT THE DEVICE HAD A LOOSE CABLE CLIP, THE WAVE WASHERS WERE REPLACED. THE DEVICE TESTED TO MANUFACTURER PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER. EVALUATION OF THE MUTING PROBE (PRODUCT # 8220325) INDICATED THAT UNIT HAD A BROKEN FERRITE AND COULD NOT BE REPAIRED. THE DEVICE WAS SCRAPPED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT PRE-OPERATIVE THE DEVICE WAS NOT WORKING PROPERLY. THERE WAS NO 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
    428038 NIM® 3.0 MAINFRAME STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253001 210129488 00643169230385

    Patients

    Seq Age Sex Outcome Treatment
    1