BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUNNELING TOOL

    MDR report key: 3242736 · Received July 23, 2013

    Report

    Report Number
    3007566237-2013-02448
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    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), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3555 CARRIER, PRODUCT TYPE: ACCESSORY. (B)(4). ANALYSIS OF THE EXTENSIONS (SERIAL #S (B)(4) AND (B)(4)) REVEALED NO ANOMALY. ANALYSIS OF THE CARRIER PART OF THE TUNNELING TOOL REVEALED IT WAS BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TUNNELING TOOL COMPONENT SEEMED TO SNAP/GIVE WAY AS BOTH THE EXTENSIONS WERE BEING PULLED THROUGH THE PASSER. ALTHOUGH NO DAMAGE COULD INITIALLY BE FOUND ON THE EXTENSIONS, THE SURGEONS WERE WORRIED ABOUT THEIR INTEGRITY AND THEY WERE REPLACED. THE REASON FOR REMOVAL WAS EXTENSION BREAKAGE. THERE WAS NO TRAUMA OR INJURY SUFFERED BY THE PATIENT. IT WAS NOTED THE SURGERY CONTINUED WITH SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344168 TUNNELING TOOL STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 3555-60 0207059771

    Patients

    Seq Age Sex Outcome Treatment
    1