BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 959272 · Received December 5, 2007

    Report

    Report Number
    2182207-2007-04258
    Event Type
    Injury
    Date Received
    December 5, 2007
    Report Date
    October 17, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    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. DUE TO THE LIMITATIONS OF THE DATA, THE REPORTABLE EVENTS ARE BEING SUBMITTED BY COMPLICATION TYPE. THE EXACT RELATIONSHIP BETWEEN EACH PT, THE DEVICES USED AND THE COMPLICATIONS EXPERIENCED WAS NOT PROVIDED. IT IS POSSIBLE THAT EACH PT MAY HAVE EXPERIENCED MORE THAN ONE COMPLICATION.

    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 OF PARKINSON'S PTS BEING TREATED WITH IMPLANTABLE DEEP BRAIN STIMULATORS. A TOTAL OF 45 PTS 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 PT COMPLICATIONS WERE NOTED DURING THE STUDY. REPORTABLE EVENT: FOUR PTS (LEAD MODEL 3389 N=4) EXPERIENCED AGITATION DURING THE PERIOPERATIVE PERIOD. TREATMENT AND OUTCOME INFO 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 UNK YR Other LEAD MODEL 3389 (N=1)| IPG ITREL II OR SOLETRA (N=1)| IPG ITREL II OR SOLETRA (N=2).| BILATERAL SYSTEMS INCLUDE: LEAD EXTENSIONS (N=2)| LEAD EXTENSIONS (N=1)| UNSPECIFIED - UNILATERAL SYSTEMS INCLUDE: