BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM RESPONSE®

    MDR report key: 4101574 · Received September 19, 2014

    Report

    Report Number
    1045254-2014-00225
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4).

    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 A THYROIDECTOMY A PATIENT EXPERIENCED RIGHT VOCAL CORD INJURY IN A CASE WHERE A MEDTRONIC NIM WAS USED. IT WAS NOTICED TOWARDS THE END OF THE CASE THAT THE NERVE WAS CUT. THEY TRIED TO SUTURE THE NERVE BACK TOGETHER. THEY ARE UNABLE TO PROVIDE THE CURRENT STATUS OF THE PATIENT AT THIS TIME AS IT WILL TAKE TIME TO TELL. THERE WAS NO ALLEGATION FROM THE FACILITY THAT THERE WAS ANY MALFUNCTION OR DEFICIENCY WITH THE NIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583887 NIM RESPONSE® STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention