BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM-ECLIPSE® PREAMPLIFIER

    MDR report key: 7151471 · Received December 28, 2017

    Report

    Report Number
    1045254-2017-00498
    Event Type
    Malfunction
    Date Received
    December 28, 2017
    Date of Event
    December 7, 2017
    Report Date
    March 23, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE PRODUCT ANALYSIS INDICATES THE DEVICE WAS RECEIVED IN GOOD COSMETIC CONDITION. THE CONNECTOR PCBA WAS TWISTED, THEREFORE THE A/D PCB (ANALOG TO DIGITAL PRINTED CIRCUIT BOARD) SHORT CIRCUITED. THE PCBA WAS REPLACED. THE DEVICE WAS SUCCESSFULLY TESTED TO SPECIFICATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE DISTRIBUTOR / CUSTOMER ALLEGED A NON-SPECIFIC DEFECT FOR THE NIM DAQ PRE-AMPLIFIER. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER INDICATES INTRAOPERATIVE, THE SYSTEM DID NOT RECOGNIZE THE DIGITAL PREAMPLIFIER. THE SYSTEM DID NOT DISPLAY IMPEDANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931831 NIM-ECLIPSE® PREAMPLIFIER STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. DAQ916 213492108 00643169378476

    Patients

    Seq Age Sex Outcome Treatment
    1