BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATOR

    MDR report key: 1161222 · Received September 15, 2008

    Report

    Report Number
    2182207-2008-05758
    Event Type
    Injury
    Date Received
    September 15, 2008
    Report Date
    August 20, 2008
    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

    SEE SCANNED PAGES.

    Description of Event or Problem · 1

    LITERATURE: TRINGALI G, BROGGI G. REVERSIBLE NEUROLOGICAL SYMPTOMS CAUSED BY DIATHERMY IN A PT WITH DEEP BRAIN STIMULATORS: CASE REPORT - COMMENTARY ON ARTICLE. NEUROSURGERY. 2008;62(1):E256. REPORTABLE EVENT: THE AUTHORS OF THE ARTICLE COMMENTARY DISCUSSED A MALE PT, IMPLANTED FOR CHRONIC CLUSTER HEADACHE WHO REPORTED AN ELECTRIC SHOCK FROM A HOME ACCIDENT WITH SUDDEN LOSS OF CONSCIOUSNESS. HE HAD BEEN IMMEDIATELY REFERRED TO THEIR DEPARTMENT. AT THE TIME OF HOSPITALIZATION, HE HAD ALREADY RECOVERED CONSCIOUSNESS. AN MRI SCAN OBTAINED AFTER APPROX. 1 HOUR DID NOT DEMONSTRATE ANY INJURES SUCH AS THAT REPEATED AT 1 MONTH. HIS IMMEDIATE POST IMPLANT MRI SCAN DID NOT SHOW ANY SIGNAL ALTERATION, SO THEY SUPPOSED THAT EDEMA CAN PLAY A PIVOTAL ROLE IN THE SPREADING OF THE CURRENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PROGRAMMER MODEL UNK N=1| LEAD MODEL UNK N=2| EXTENSION MODEL UNK N=2