BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1324324 · Received February 23, 2009

    Report

    Report Number
    2182207-2009-01237
    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. THREE DYSTONIA PATIENTS EXPERIENCED SLIPPED LEADS THAT WERE DETECTED AT 12 MONTHS POST-OP. ALL PATIENTS WERE SUCCESSFULLY REIMPLANTED FOLLOWING WHICH CONTINUOUS SUSTAINED IMPROVEMENT 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 UNK

    Patients

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