BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM-ECLIPSE® PREAMPLIFIER

    MDR report key: 6015408 · Received October 10, 2016

    Report

    Report Number
    1045254-2016-00332
    Event Type
    Malfunction
    Date Received
    October 10, 2016
    Report Date
    September 15, 2016
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    PMA / PMN Number
    K050798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. A PRODUCT ANALYSIS HAS NOT BEEN PERFORMED. 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.

    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 DAQ916 MODULE (DIGITAL PREAMPLIFIER) WAS DEFECTIVE. A SPARE MODULE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665866 NIM-ECLIPSE® PREAMPLIFIER STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. DAQ916

    Patients

    Seq Age Sex Outcome Treatment
    1