BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 939863 · Received November 6, 2007

    Report

    Report Number
    2182207-2007-03731
    Event Type
    Injury
    Date Received
    November 6, 2007
    Report Date
    October 14, 2007
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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: BROGGI, ET AL. "DEEP BRAIN STIMULATION AS A FUNCTIONAL SCALPEL." ACTA NEUROCHIR SUPPL 2006, 99:13-19. THE ARTICLE REPORTS ON THE RESULTS OF A RETROSPECTIVE STUDY INVOLVING THE TREATMENT OF SEVERAL DRUG-RESISTANT NEUROLOGICAL SYNDROMES WITH DEEP BRAIN STIMULATION (DBS). A TOTAL OF LEADS WERE IMPLANTED IN PATIENTS. A NUMBER OF PATIENT COMPLICATIONS WERE REPORTED AS PART OF THE STUDY RESULTS. REPORTABLE EVENTS: THREE PATIENTS (DBS LEADS N=3) EXPERIENCED POST OPERATIVE SEIZURES.TREATMENT AND OUTCOME INFORMATION WAS NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other MICRO RECORDING ELECTRODE| LEAD EXTENSIONS| IMPLANTABLE LEAD| IMPLANTABLE PULSE GENERATOR| FOR EACH PATIENT: