BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 959424 · Received December 5, 2007

    Report

    Report Number
    2182207-2007-04252
    Event Type
    Death
    Date Received
    December 5, 2007
    Report Date
    October 17, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL REFERENCE: ORY-MAGNE, MD., ET AL. "DOES AGEING INFLUENCE DEEP BRAIN STIMULATION OUTCOMES IN PARKINSON'S DISEASE" MOVEMENT DISORDERS, 2007, 22:1457-1463. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: ORY-MAGNE, MD., ET AL. "DOES AGEING INFLUENCE DEEP BRAIN STIMULATION OUTCOMES IN PARKINSON'S DISEASE" MOVEMENT DISORDERS, 2007, 22:1457-1463. THE ARTICLE DESCRIBES THE RESULTS FROM A STUDY THAT RECORDED ADVERSE EVENTS ENCOUNTERED DURING FOLLOW-UP PARKINSONS PATIENTS BEING TREATED WITH IMPLANTABLE DEEP BRAIN STIMULATORS. A TOTAL OF 45 PATIENTS UNDERWENT PROCEDURES FOR IMPLANTATION OF UNILATERAL (2 CASES) OR BILATERAL DBS SYSTEMS. THE GOAL OF THE STUDY WAS TO DETERMINE IF AGE WAS A FACTOR IN TREATMENT SUCCESS. A NUMBER OF PATIENT COMPLICATIONS WERE NOTED DURING THE STUDY. REPORTABLE EVENT: A PT (LEAD MODEL 3389 N=1) EXPERIENCED SYMPTOMATIC CEREBRAL BLEEDING AND SUBSEQUENTLY EXPIRED (PERIOPERATIVE PERIOD).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death IPG ITREL II OR SOLETRA (N=1)| UNSPECIFIED - UNILATERAL SYSTEMS INCLUDE:| MICROELECTRODE-RECORDING (UNK MFG)| LEAD EXTENSIONS (N=1)| LEAD MODEL 3389 (N=1)| BILATERAL SYSTEMS INCLUDE: LEAD EXTENSION (N=2)| IPG ITREL II OR SOLETRA (N=2)