BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE STIMULATOR

    MDR report key: 3190599 · Received June 26, 2013

    Report

    Report Number
    3007566237-2013-02117
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37085-60, SERIAL# (B)(4). PRODUCT TYPE: EXTENSION: PRODUCT ID NEU_TUNNELINGTOOL. PRODUCT TYPE: ACCESSORY: PRODUCT ID NEU_UNKNOWN_EXT. PRODUCT TYPE: EXTENSION: PRODUCT ID NEU_CARRIER/1X4. PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BILATERAL BATTERY REPLACEMENT, WHILE OPENING THE BATTERY POCKET, AN EXTENSION CONNECTED TO AN OLD STIMULATOR WAS ACCIDENTALLY. A NEW EXTENSION WAS OPENED. THE SURGEON BEGAN TO TUNNEL THE AREA, BUT HAD TROUBLE MAKING A CLEAR PASSAGE. FOLLOWING THE TUNNELING THROUGH THE NECK, THE EXTENSION WAS LOADED ONTO THE CARRIER AND INSERTED INTO THE TUNNELLER. THE EXTENSION AND CARRIER WERE PULLED THROUGH THE BATTERY POCKET TO THE TOP OF THE HEAD. WHILE DOING SO, THE CARRIER APPEARED TO BE CAUGHT HALFWAY. THE SURGEON PULLED THE TUNNELLER THROUGH, BUT ONLY THE CARRIER CAME THROUGH. HALF OF THE TOP PART OF THE CARRIER WAS MISSING/BROKEN. THE SURGEON PULLED THE EXTENSION FROM THE POCKET INCISION. THE EXTENSION GAVE AND WAS PULLED OUT, BUT THE TOP PART THAT WAS IN THE CARRIER HAD BROKEN OFF. AN INCISION WAS MADE IN THE NECK OF THE PATIENT AND THE TOP PART OF THE BROKEN EXTENSION AND THE BROKEN CARRIER PIECE WERE FOUND. A NEW EXTENSION WAS OPENED, RETUNNELLED AND SUCCESSFULLY IMPLANTED. THE PATIENT RECOVERED FULLY.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT DEVICES WERE DISCARDED BY THE HOSPITAL AND NOT AVAILABLE FOR ANALYSIS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290037 UNKNOWN IMPLANTABLE STIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention