BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 963712 · Received December 12, 2007

    Report

    Report Number
    2182207-2007-04351
    Event Type
    Injury
    Date Received
    December 12, 2007
    Report Date
    October 17, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL REFERENCE: ZHANG, ET AL. "DEEP BRAIN STIMULATION IN THE TREATMENT OF SECONDARY DYSTONIA." CHINESE MEDICAL JOURNAL, 2006; 119(24):2069-2074.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: ZHANG, ET. AL. "DEEP BRAIN STIMULATION IN THE TREATMENT OF SECONDARY DYSTONIA." CHINESE MEDICAL JOURNAL. 2006; 119(24): 2069-2074. THE ARTICLE DESCRIBES THE RESULTS FROM A STUDY THAT INVOLVED A SERIES OF 9 PATIENTS TREATED WITH UNILATERAL AND BILATERAL DEEP DRAIN STIMULATION (DBS) FOR MANAGEMENT OF SYMPTOMS RELATED TO SECONDARY DYSTONIA. A NUMBER OF COMPLICATIONS WERE DESCRIBED. REPORTABLE EVENT: A MALE PATIENT EXPERIENCED A LEFT SIDE LEAD FRACTURE AT 16 MONTHS POST DBS IMPLANT THAT REQUIRED THE REPLACEMENT OF THE LEAD. OUTCOME INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MEDTRONIC NEUROMODULATION 3389 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| R LEAD MODEL 3389 (N=1)| KINETRA MODEL 7428| LEAD EXTENSIONS (N=2)