BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVICE 8252410 NIM-NEURO 2.0 INTERFACE

    MDR report key: 3640020 · Received February 21, 2014

    Report

    Report Number
    1045254-2014-00041
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 27, 2014
    Report Date
    January 27, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    IKN
    PMA / PMN Number
    K024316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT MEDICAL PRODUCTS: 8252401, MAINFRAME 8252401 NIM-NEURO 2.0, S/N (B)(4), LOT: 39240600. 510K: K024316. MANUFACTURED JULY 21, 2005. (B)(4). PRODUCT EVALUATION: THE FACILITY HAS CONFIRMED THAT THE DEVICE HAS BEEN TAKEN OUT OF SERVICE DUE TO AGE; IT WILL NOT BE RETURNED FOR ANALYSIS. METHOD: NO TESTING METHODS PERFORMED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT INTERFACE HAS AN INTERMITTENT CONNECTION WHEN THE CABLE IS BUMPED. IT WAS CONFIRMED WITH PHYSICIAN THAT THE DEVICE WAS MAKING STRANGE, UNEXPECTED NOISES. IT HAS ALSO BEEN CONFIRMED THAT MONITORING WOULD STOP, AND AFTER MANIPULATION OF THE INTERFACE BOX, WOULD START UP AGAIN. THE PHYSICIAN REVERTED TO CLINICAL JUDGMENT FOR THE REMAINDER OF THE PROCEDURE, THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109821 DEVICE 8252410 NIM-NEURO 2.0 INTERFACE ELECTROMYOGRAPH, DIAGNOSTIC IKN MEDTRONIC XOMED INC. 8252410 NI

    Patients

    Seq Age Sex Outcome Treatment
    1