BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATINUM SUBDERMAL NEEDLE ELECTRODES

    MDR report key: 3836049 · Received May 2, 2014

    Report

    Report Number
    3005581270-2014-00002
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    August 6, 2013
    Report Date
    March 31, 2014
    Manufacturer
    GRASS TECHNOLOGIES
    Product Code
    IKT
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS BEEN CONTACTED TO PROVIDE THE REST OF THE REQUIRED INFORMATION. WE ARE IN THE PROCESS OF GATHERING ADDITIONAL INFORMATION. A LETTER LISTING OUTSTANDING INFORMATION HAS BEEN SENT TO CUSTOMER TO OBTAIN ADDITIONAL INFORMATION IN ORDER TO SUBMIT FOLLOW UP REPORT AND/OR EXPLAIN WHY REQUIRED INFORMATION WAS NOT PROVIDED AND STEPS TAKEN TO OBTAIN SUCH INFORMATION.

    Description of Event or Problem · 1

    TWO SKIN BURNS NOTED AT THE END OF OR PROCEDURE NEAR SITE OF INTRA OPERATIVE NEURO MONITORING LEADS - PATIENT UNDERWENT INTRAOPERATIVE MRI WITH THESE SUBDERMAL PLATINUM LEADS IN PLACE FOR INTRAOPERATIVE NEUROMONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264019 PLATINUM SUBDERMAL NEEDLE ELECTRODES SUBDERMAL ELECTRODES, 882.1350 IKT GRASS TECHNOLOGIES F-E2-48

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other