BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATINUM SUBDERMAL NEEDLE ELECTRODES

    MDR report key: 3836050 · Received May 2, 2014

    Report

    Report Number
    3005581270-2014-00001
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    March 18, 2014
    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)(6) CONTRACTS WITH (B)(4) USING THEIR EVOKED POTENTIAL (EP) DEVICE TO MONITOR SURGERIES. (B)(4) USES NATUS XLTEK PROTEKTOR EP DEVICE IN THE ELECTRO SURGICAL UNIT (ESU) USING RADIO FREQUENCY (RF) DEVICE. ASSUMING THAT RF CURRENT OR STRAY RF LEAKAGE ARE CONTRIBUTING FACTORS TO THE BURNS. THE PLATINUM SUBDERMAL NEEDLE ELECTRODE IS PASSIVE.

    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

    THREE BURNS NOTED WHEN DRAPES REMOVED AFTER SURGERY DURING WHICH SUBDERMAL ELECTRODES WERE PLACED IN THESE AREAS OF THE FACE AND TWO AREAS ON UPPER STERNUM. PATIENT HAD INTER-OPERATIVE MRI WITH LEADS IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263831 PLATINUM SUBDERMAL NEEDLE ELECTRODES SUBDERMAL ELECTRODES, 882.1350 IKT GRASS TECHNOLOGIES F-E2-48

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other