BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 939860 · Received November 6, 2007

    Report

    Report Number
    2182207-2007-03734
    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

    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 EVENT: PATIENT EXPERIENCED A CEREBRAL ABSCESS AT THE ORIGIN OF THE STEREOTACTIC TRAJECTORY SITE. NO INFORMATION CONCERNING TREATMENT AND OUTCOME WAS 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 Required Intervention EXTENSION MODEL EXTENSION MVD LOT# UNK| LOT# UNK| IMPLANTABLE LEAD (1)| EXPLANTED| IMPLANTED| IMPLANTABLE PULSE GENERATOR MODEL IPGNEURO| IMPLANTED| MICRO RECORDING ELECTRODE| LEAD EXTENSIONS (2)| IMPLANTABLE PULSE GENERATOR (1)| EXPLANTED