BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM-ECLIPSE® PREAMPLIFIER

    MDR report key: 7372098 · Received March 26, 2018

    Report

    Report Number
    1045254-2018-00130
    Event Type
    Malfunction
    Date Received
    March 26, 2018
    Report Date
    June 6, 2018
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    UDI-DI
    00643169378476
    PMA / PMN Number
    K050798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ANALYSIS IS AVAILABLE; THE DEVICE HAS BEEN RECEIVED BUT EVALUATION HAS NOT BEGUN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE DAQ WAS RETURNED FOR ANALYSIS WHERE IT WAS TESTED, AND NO MALFUNCTIONS WERE FOUND. AS A PRECAUTION, THE JACK WAS CHECKED FOR CONTINUITY WITH NO FINDINGS AS WELL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. A PRODUCT ANALYSIS HAS NOT BEEN COMPLETED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE REPORTED INFORMATION INDICATES THAT THE DAQ BOX WAS NOT WORKING PROPERLY, AND THE CUSTOMER WAS ALERTED VISUALLY.

    Description of Event or Problem · 1

    THE REPORTED INFORMATION INDICATES THAT THE DAQ BOX WAS NOT WORKING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212808 NIM-ECLIPSE® PREAMPLIFIER STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. DAQ916 213041446 00643169378476

    Patients

    Seq Age Sex Outcome Treatment
    1