BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 959258 · Received December 5, 2007

    Report

    Report Number
    2182207-2007-04245
    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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL REFERENCE: NOVAK, ET AL. "TWO CASES OF ISCHEMIA ASSOCIATED WITH SUBTHALAMIC NUCLEUS STIMULATOR IMPLANTATION FOR ADVANCED PARKINSON'S DISEASE". MOVEMENT DISORDERS, 2006, 21:1477-1483. DUE TO THE LIMITATIONS OF THE DATA, THE REPORTABLE EVENTS ARE BEING SUBMITTED BY COMPLICATION TYPE. THE EXACT RELATIONSHIP BETWEEN EACH PATIENT, THE DEVICES USED AND THE COMPLICATIONS EXPERIENCED WAS NOT PROVIDED. IT IS POSSIBLE THAT EACH PATIENT MAY HAVE EXPERIENCED MORE THAN ONE COMPLICATION.

    Description of Event or Problem · 1

    JOURNAL REFERENCE: NOVAK, ET AL. "TWO CASES OF ISCHEMIA ASSOCIATED WITH SUBTHALAMIC NUCLUEUS STIMULATOR IMPLANTATION FOR ADVANCED PARKINSON'S DISEASE". MOVEMENT DISORDERS, 2006, 21:1477-1483. THE ARTICLE DESCRIBES TWO CASE STUDIES THAT INVOLVE ISCHEMIA ASSOCIATED WITH THE IMPLANT OF SUBTHALAMIC NUCLEUS STIMULATORS IN ADDITION, OTHER COMPLICATIONS FROM A SERIES OF 41 PATIENTS TREATED WITH DBS FOR SYMPTOMS RELATED TO ADVANCED STAGE PD OVER THE LAST 5.5 YEARS ARE ALSO PRESENTED. REPORTABLE EVENTS: TWO PATIENTS (LEAD MODEL 3389 N=2) EXPERIENCED INTRACRANIAL HEMORRHAGES - ICH. NO SYMPTOM, TREATMENT INFO WAS 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 UNKNOWN Other IPG SOLETRA 7426 (N=2)| DBS LEAD MODEL 3389 (N=1)| LEAD EXTENSIONS (N=2)| MICROELECTRODE - RECORDING (MFG FHC)