BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DBS LEAD

    MDR report key: 3252910 · Received July 29, 2013

    Report

    Report Number
    3007566237-2013-02507
    Event Type
    Injury
    Date Received
    July 29, 2013
    Report Date
    July 2, 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 PRODUCTS: PRODUCT ID; 924256, LOT# 082205613A, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 924256, LOT# 082234812A, IMPLANTED: (B)(6) 2013. PRODUCT TYPE: ACCESSORY. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING IMPLANT BOTH THE RIGHT AND LEFT LEADS MIGRATED 3 MM AND 1.5 MM, RESPECTIVELY, CAUDALLY WHEN THE MICRO DRIVE WAS REMOVED DESPITE THE JAWS OF THE INNER CLIP OF THE BURR HOLE BEING CLOSED. THE SURGEON WAS ABLE TO FIX THE POSITION AND PLACED THE CAP ON THE BASE RING FOR THE RIGHT LEAD. FOR THE LEFT LEAD THE SURGEON MADE SEVERAL ATTEMPTS BEFORE RETURNING THE LEAD TO THE CORRECT POSITION AND PLACING THE CAP ON THE BASE RING. IT WAS NOTED THE FAILURE OF THE INNER CLIP OF BOTH CAPS CAUSED A DELAY OF 5-10 MINUTES PER SIDE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351852 UNKNOWN DBS LEAD STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_UNKNOWN_LEAD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1