BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3173730 · Received June 17, 2013

    Report

    Report Number
    3007566237-2013-02002
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 24, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 924256, LOT# 082234812A, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: ACCESSORY: PRODUCT ID 924256, LOT# 082234812A, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: ACCESSORY: PRODUCT ID 3550S-01, LOT# 082334211, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON DRILLED A 14 MM BURR HOLE AND SECURED THE BASE RING USING THE PRESCRIBED TECHNIQUE. MER AND STIM WERE CONDUCTED USING THE 34680 ELECTRODE. THE 3387-40 LEAD WAS THEN IMPLANTED. THE SURGEON PLACED THE INNER CLIP OF THE STIMLOC IN THE BASE RING AND SEARED IT CORRECTLY. HE THEN CLOSED THE JAWS SUCCESSFULLY; HOWEVER, HE NOTED THAT THE LEAD WAS STILL MOBILE DESPITE THE JAWS BEING CLOSED. THE LEAD WAS STILL BEING HELD BY THE MICRO DRIVE. HE REMOVED THE INNER CLIP AND CLEANED OUT THE BURR HOLE. HE REPEATED THE PROCESS WITH THE SAME OUTCOME. A NEW INNER CLIP WAS OPENED AND THE SURGEON WAS ABLE TO SEAT IT WITHIN THE BASE RING AND CLOSED THE JAWS. AGAIN THE LEAD WAS NOT BEING HELD. THE SURGEON THEN DID FURTHER DRILLING AND REPEATED THE PROCESS WITH THE SAME OUTCOME. HE THEN REMOVED THE BASE RING AND SCREWED IT IN, IN A DIFFERENT ORIENTATION. A NEW STIMLOC CAP WAS USED WITH THE SAME OUTCOME. THE CLIP WAS DROPPED AS IT WAS BEING REMOVED. A NEW STIMLOC CAP WAS OPENED AND IMPLANTED WITH THE SAME OUTCOME. AT THIS POINT 45 MINUTES HAD ELAPSED SO THE SURGEON ELECTED TO PROCEED WITH PLACING THE CAP ON THE STIMLOC. TESTING WAS CONDUCTED THROUGH THE LEAD TO ENSURE IT HAD NOT MOVED. THIS ISSUE RESULTED IN A 50 MINUTE DELAY TO THE CASE. THE PATIENT RECOVERED FULLY.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE CAUSE OF THE PROBLEM WAS UNABLE TO BE DETERMINED SINCE THE DEVICES WERE NOT RETURNED 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
    273181 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 3387-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention