BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1324325 · Received February 23, 2009

    Report

    Report Number
    2182207-2009-01238
    Event Type
    Injury
    Date Received
    February 23, 2009
    Report Date
    March 27, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.

    Description of Event or Problem · 1

    LITERATURE: YIANNI J ET AL. "INCREASED RISK OF LEAD FRACTURE AND MIGRATION IN DYSTONIA COMPARED WITH OTHER MOVEMENT DISORDERS FOLLOWING DEEP BRAIN STIMULATION." JOURNAL OF CLINICAL NEUROSCIENCE. 2004. 11(3):243-245. ABOUT 4 DYSTONIA PATIENTS EXPERIENCED FRACTURED LEADS WITH DETECTION OCCURRING AT 5, 6, 18 AND 23 MONTHS POSTOP. THE CLINICAL CONDITION WAS GRADUAL, OCCURRING OVER SEVERAL WEEKS. THE FRACTURE WAS MOST COMMONLY NOTED TO BE AT THE POINT WHERE THE LEAD WAS HELD UNDER THE METAL PLATE AGAINST THE SKULL (IN THREE PATIENTS) AND THE FOURTH PATIENT'S FRACTURE COULD NOT BE DETERMINED. ALL PATIENTS WERE SUCCESSFULLY REIMPLANTED FOLLOWING WHICH CONTINUOUS SUSTAINED IMPROVEMENTS IN THEIR RESPECTIVE CLINICAL CONDITIONS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MEDTRONIC NEUROMODULATION 3387 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD, MODEL 3387| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387| IMPLANTED:| EXPLANTED:| IMPLANTABLE PULSE GENERATOR: MODEL IPGNEURO| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL PROGRAMMER| LOT# UNKNOWN| LEAD: MODEL 3387| EXPLANTED: