BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® 3.0 INTERFACE

    MDR report key: 6931765 · Received October 9, 2017

    Report

    Report Number
    1045254-2017-00353
    Event Type
    Malfunction
    Date Received
    October 9, 2017
    Date of Event
    September 8, 2017
    Report Date
    September 14, 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

    MEDICAL DEVICES: (B)(4) - NIM MAINFRAME RESPONSE 3.0, SERIAL # (B)(4), LOT # 66456200, MANUFACTURED DATE ¿ FEB/26/2010, 510(K) # K083124, UDI # (B)(4). THE NIM PATIENT INTERFACE (PRODUCT # 8253200RF) WAS RETURNED FOR ANALYSIS. EVALUATION FOUND THAT THE DEVICE HAD A DEFECTIVE PCBA AND AN INCREMENTING PROBE FAILURE. EVALUATION ALSO FOUND THAT THE UNIT CAME IN WITH TWO INCORRECT FUSES AND HAD A MISSING O-RING. THE DEVICE WAS REPAIRED, MISSING ITEMS WERE INSTALLED, INCORRECTED ITEMS WERE REPLACED, TESTED TO MANUFACTURER PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER. THE NIM MAINFRAME RESPONSE (PRODUCT # 8253001) WAS RETURNED FOR ANALYSIS. EVALUATION COULD NOT DUPLICATE REPORTED EVENT OF INTERMITTENT FAILURE. EVALUATION FOUND NO FAULT WITH THE DEVICE. THE DEVICE WAS TESTED TO MANUFACTURER PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT IN TWO PROCEDURES, INTRA-OPERATIVE THE NIM SYSTEM WAS GIVING INTERMITTENT READINGS WHEN IT WAS "FIRED." THE FIRST PROCEDURE OCCURRED ON (B)(6) 2017 AND THE SECOND PROCEDURE OCCURRED ON (B)(6) 2017. BOTH PROCEDURES WERE COMPLETED. THERE WAS NO REPORT OF PATIENT IMPACT ON BOTH PROCEDURES. THIS REGULATORY REPORT IS BEING FILED FOR PROCEDURE 1 OF 2 THAT OCCURRED ON (B)(6) 2017 (MEDTRONIC INTERNAL REFERENCE NUMBER (B)(4)). ANOTHER REGULATORY REPORT WILL BE FILED FOR PROCEDURE 2 OF 2 THAT OCCURRED ON (B)(6) 2017 (MEDTRONIC INTERNAL REFERENCE NUMBER (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711494 NIM® 3.0 INTERFACE STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. 8253200RF 71530900 00613994858399

    Patients

    Seq Age Sex Outcome Treatment
    1