BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® 3.0 INTERFACE

    MDR report key: 6888149 · Received September 22, 2017

    Report

    Report Number
    1045254-2017-00331
    Event Type
    Malfunction
    Date Received
    September 22, 2017
    Report Date
    August 28, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    UDI-DI
    00613994858399
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 8253001: NIM MAINFRAME RESPONSE 3.0, SERIAL (B)(4), LOT # 66456200, MANUFACTURED DATE ¿ FEB/26/2010, 510(K) # K083124, (B)(4). THE NIM PATIENT INTERFACE (PRODUCT # 8253200) WAS RETURNED FOR ANALYSIS. EVALUATION FOUND THAT THE DEVICE HAS A WORN WAVE WASHER, A CRACKED BACK ENCLOSURE AND A SCRATCHED MEDTRONIC SYMBOL. ANALYSIS ALSO INDICATED THAT THE DEVICE CAME IN WITH TWO MISSING O-RINGS AND TWO MISSING SPARE FUSES. THE DEVICE WAS REPAIRED, MISSING ITEMS WERE INSTALLED, TESTED TO MANUFACTURER PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER. THE NIM MAINFRAME RESPONSE (PRODUCT # 8253001) WAS RETURNED FOR ANALYSIS. EVALUATION FOUND THAT THE UNIT CAME IN WITH TWO MISSING FEET AND THE DEVICE HAD A MUTING PROBE FAILURE. THE AUDIO BOARD WAS DEFECTIVE. THE DEVICE WAS REPAIRED, THE SOFTWARE WAS UPGRADED TO CURRENT SPECIFICATIONS, TESTED TO MANUFACTURER PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER. 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 INTRA-OPERATIVE THE NIM SYSTEM WAS GIVING AN INTERMITTENT RESPONSE. THE SYSTEM WOULD RESPOND SOMETIMES AND SOMETIMES IT WOULD NOT. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THERE WERE THREE OCCURRENCES OF THIS EVENT WITH THIS SYSTEM. EVENT 1 OF 3 WAS FILED UNDER REGULATORY REPORT # 1045254-2017-00330 ((B)(4)). THIS REGULATORY REPORT IS BEING FILED FOR EVENT 2 OF 3 ((B)(4)). EVENT 3 OF 3 OCCURRED ON (B)(6) 2017 AND WAS FILED UNDER THE REGULATORY REPORT # 1045254-2017-00297 ((B)(4)). EVENT DATES OR SPECIFIC INFORMATION FOR EVENTS 1 OF 3 AND 2 OF 3 ARE UNKNOWN. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FOR THESE PREVIOUS EVENTS HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667257 NIM® 3.0 INTERFACE STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. 8253200 66888400 00613994858399

    Patients

    Seq Age Sex Outcome Treatment
    1