BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBDERMAL NEEDLE ELECTRODES

    MDR report key: 5547879 · Received May 8, 2014

    Report

    Report Number
    1067162-2014-00001
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    January 14, 2014
    Report Date
    March 18, 2016
    Manufacturer
    RHYTHMLINK INTERNATIONAL, LLC
    Product Code
    GXZ
    PMA / PMN Number
    K022914
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INCOMING INSPECTION FOR ALL RAW MATERIALS USED IN THE PRODUCTION LOT SHOWED NO ABNORMALITIES OR RAW MATERIAL FAILURES. PRODUCTION OF THIS DEVICE USED STANDARD RAW MATERIALS AND PROCESSES. NO PRODUCTION ABNORMALITIES WERE NOTED. NO SHIPMENT OR STORAGE ABNORMALITIES WERE NOTED FOR THIS PRODUCTION LOT. THIS PRODUCTION LOT CONTAINED (B)(4) NEEDLES. NO OTHER CUSTOMER COMPLAINTS, ISSUES OR FAILURES WERE ASSOCIATED WITH THIS PRODUCTION LOT.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A SPINAL FUSION IN OPERATING ROOM 8 WITHOUT COMPLICATIONS. AFTER THE PROCEDURE WAS OVER, BUT BEFORE THE PATIENT LEFT THE OPERATING ROOM, WHEN THE NEUROMONITORING NEEDLE ELECTRODES WERE BEEN REMOVED FROM THE PATIENT, IT WAS NOTED BY THE NURSE AND NEUROPHYSIOLOGIST THAT THERE WAS A PINPOINT DERMAL DISCOLORATION ON THE LEFT ANTERIOR LEG UPPER AND LOWER LEG. PHYSICIAN NOTIFIED. PATIENT TAKEN TO RECOVERY ROOM. NOTE THE ABOVE DERMAL DISCOLORATION HAS OCCURRED IN THE FOLLOWING: PATIENT #2 AFTER SPINAL FUSION COMPLETED, WHILE REMOVING NEURO MONITORING ELECTRODES, DERMAL DISCOLORATION NOTED RIGHT ANTERIOR THIGH. ROOM 8. PATIENT #3 - AFTER SPINAL FUSION COMPLETED, WHILE REMOVING NEURO MONITORING ELECTRODES, DERMAL DISCOLORATION ON QUADRICEP NOTED. ROOM 8. PATIENT #4 - AFTER SPINAL FUSION COMPLETED. WHILE REMOVING NEURO MONITORING ELECTRODES, DERMAL DISCOLORATION ON CALF NOTED. ROOM 8. PATIENT #5 - AFTER SPINAL FUSION COMPLETED, WHILE REMOVING NEURO MONITORING ELECTRODE, DERMAL DISCOLORATION MARK ON POSTERIOR UPPER ARM AND TIBIALIS ANTERIOR NOTED. ROOM 8. PATIENT #6 - AFTER SPINAL FUSION COMPLETED, WHILE REMOVING NEURO MONITORING ELECTRODE, DERMAL DISCOLORATION ON LEFT SHOULDER, LEFT THIGH, RIGHT ANTERIOR THIGH NOTED. ROOM 8. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? SPINAL FUSION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280592 SUBDERMAL NEEDLE ELECTRODES SUBDERMAL NEEDLE ELECTRODES GXZ RHYTHMLINK INTERNATIONAL, LLC RLSND121-2.5 0002494, 00002687

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other