BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 959269 · Received December 5, 2007

    Report

    Report Number
    2182207-2007-04260
    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

    .

    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 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 EVENTS: FIVE PATIENTS (PG N=5) EXPERIENCED INFECTIONS DURING THE POSTOPERATIVE PERIOD. TREATMENT AND OUTCOME INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK MHY MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention IMPLANTED| LEAD MODEL 3389 LOT#UNK| BILATERAL SYSTEMS INCLUDE: LEAD EXTENSIONS (N=2)| IMPLANTED| LOT#UNK| IMPLANTABLE PULSE GENERATOR MODEL IPGNEURO| EXPLANTED| EXPLANTED| EXPLANTED| LEAD MODEL 3389 (N=1)| LEAD EXTENSIONS (N=1)| UNSPECIFIED- UNILATERAL SYSTEMS INCLUDE:| IMPLANTED| EXPLANTED| IMPLANTED| LEAD MODEL 3389 LOT#UNK| LEAD MODEL 3389(N=2)| EXTENSION MODEL EXTENSION LOT#UNK| IPG ITRELL II OR SOLETRA (N=1).