BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM-ECLIPSE® CONTROLLER

    MDR report key: 4973460 · Received August 5, 2015

    Report

    Report Number
    1045254-2015-00264
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    June 17, 2015
    Report Date
    July 14, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED ON AUGUST 20, 2015. (B)(4). THE PRODUCT ANALYSIS WAS COMPLETED ON SEPTEMBER 4, 2015. THE PRODUCT ANALYSIS INDICATES THAT THERE WAS NO COMMUNICATION. THE CONNECTOR BOARD WAS REPLACED. THE DEVICE WAS TESTED AND PASSED MANUFACTURING SPECIFICATIONS. METHOD: ACTUAL DEVICE EVALUATED; VISUAL INSPECTION; LABELING EVALUATION. RESULT: ELECTRICAL PROBLEM. CONCLUSION: DEVICE REPAIRED AND RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). DEVICE NOT CLEARED IN US, BUT SIMILAR DEVICE IS AVAILABLE. THE DEVICE HAS NOT BEEN RETURNED. THEREFORE, A PRODUCT ANALYSIS HAS NOT BEEN PERFORMED. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    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 DURING USE, THE DEVICE WAS NOT WORKING. REQUESTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE WITH NO ADDITIONAL INFORMATION PROVIDED AT THIS TIME. THERE WAS NO INJURY REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515469 NIM-ECLIPSE® CONTROLLER STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. ECLC 207170878

    Patients

    Seq Age Sex Outcome Treatment
    1