BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEE-1000A

    MDR report key: 5515516 · Received March 21, 2016

    Report

    Report Number
    8030229-2016-00020
    Event Type
    Malfunction
    Date Received
    March 21, 2016
    Date of Event
    April 13, 2011
    Report Date
    April 14, 2011
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    GWF
    PMA / PMN Number
    K051178
    Removal / Correction Number
    REPORT PENDING
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AFFECTED UNITS WERE CORRECTED USING NEW PCBS WITH CORRECTED CIRCUITS AFTER REDESIGN. DEVICES WERE CORRECTED ON HOSPITAL SITES AND AT NIHON KOHDEN AMERICA INC. SUBSEQUENT COMPLAINT REVIEW AS OF JANUARY 7, 2016 SHOWS NO COMPLAINTS ON THIS ISSUE POST CORRECTION. AN UNREPORTED FIELD CORRECTION WAS CONDUCTED FOLLOWING THIS INCIDENT. AS PART OF THE RETROSPECTIVE REVIEW, THIS CORRECTION WILL BE REPORTED TO THE FDA. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN INCIDENT OCCURRED IN THE OR WITH THE DEVICE REGARDING AN UNEXPECTED RESPONSE DURING PEDICLE SCREW STIMULATION WHERE THE PATIENT HAD A "TETANIC" RESPONSE UPON DELIVERY OF THE STIMULUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170139 MEE-1000A EVOKED RESPONSE ELECTRIC STIMULATOR GWF NIHON KOHDEN CORPORATION ME-1000A

    Patients

    Seq Age Sex Outcome Treatment
    1