BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® 3.0 MAINFRAME INTERNATIONAL

    MDR report key: 6354510 · Received February 23, 2017

    Report

    Report Number
    1045254-2017-00066
    Event Type
    Malfunction
    Date Received
    February 23, 2017
    Report Date
    January 30, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    UDI-DI
    00613994529053
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: 8253200 - PATIENT INTERFACE, NIM RESPONSE 3.0; SERIAL NUMBER - (B)(4); LOT NUMBER 207149875; MANUFACTURED DATE ¿ JULY 3, 2013; UDI NUMBER ¿ (B)(4); 510K ¿ K083124. PRODUCT 8253002 (MAINFRAME): THE PRODUCT ANALYSIS INDICATES THAT THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE DEVICE WAS SUCCESSFULLY TESTED TO SPECIFICATIONS. THERE WAS NO FAULT FOUND. PRODUCT 8253200 (PATIENT INTERFACE): THE PRODUCT ANALYSIS INDICATES THAT THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE PATIENT INTERFACE WORKED NORMALLY AND WAS RECEIVED IN GOOD COSMETIC CONDITION. THE LOOSE ASSEMBLY CLIPS AND WORN WAVE WASHERS WERE REPLACED. THE DEVICE WAS SUCCESSFULLY TESTED TO SPECIFICATIONS. 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

    IT WAS REPORTED THAT THE DEVICE(S) WERE DEFECTIVE AND THERE WAS NO STIMULATION. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136280 NIM® 3.0 MAINFRAME INTERNATIONAL STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253002 208131486 00613994529053

    Patients

    Seq Age Sex Outcome Treatment
    1