BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3120671 · Received May 20, 2013

    Report

    Report Number
    3007566237-2013-01678
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    October 1, 2003
    Report Date
    April 26, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    BRANDAO, E., ROSAS, M. J., ABREU, P., LINHARES, P., VAZ, R. INTRACEREBRAL ABSCESS: A RARE COMPLICATION OF DEEP BRAIN STIMULATION. NE UROCIRUGIA. 2013;24(1):33-36. DOI: 10.1016/J.NEUCIR.2011.11.008. SUMMARY/REPORTED EVENT: A 59-YEAR-OLD MALE WHO HAD SUFFERED PARKINSON'S DISEASE (PD) FOR 19 YEARS WAS SUBMITTED TO BILATERAL SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION (DBS) IN (B)(6) 2003, WHEN HE WAS (B)(6). THE PATIENT DEVELOPED AN INFLAMMATORY REACTION OF THE SKIN AND SUBCUTANEOUS TISSUE SURROUNDING THE AREA OF THE SUBCUTANEOUS DEVICE SYSTEM ONE MONTH AFTER IMPLANTATION. NO INFECTIOUS AGENT WAS ISOLATED, AND SKIN ALLERGIES TESTS TO TALC GLOVES AND TO THE DEVICE MATERIAL WERE NEGATIVE. IN THE FOLLOWING 12 MONTHS, THE PATIENT REQUIRED 5 MAJOR SURGERIES DUE TO A PROCESS OF SYSTEMATIC INFLAMMATION/INFECTION THROUGHOUT DIFFERENT LOCATIONS OF THE DEVICE SYSTEM. A FEW DAYS AFTER REMOVAL OF THE DEVICE SYSTEM, THE PATIENT DEVELOPED A RIGHT OCULOMOTOR NERVE PARESIS AND MILD LEFT HEMIPARESIS. HE HAD FEVER, HEADACHE, SOMNOLENCE, AND NUCHAL RIGIDITY. A CT SCAN REVEALED AN ABSCESS IN THE RIGHT THALAMO-MESENCEPHALIC AREA. A STAPHYLOCOCCUS AUREAUS WAS ISOLATED FROM CEREBROSPINAL FLUID, AND THE PATIENT STARTED ANTIBIOTIC TREATMENT DURING 21 DAYS WITH IMPROVEMENT OF HIS STATE. HE WAS A SLIGHT DIPLOPIA, MILD LEFT HEMIPARESIS, AND NO PARKINSONIC TREMOR, BRADYKINESIA AND RIGIDITY ON THE OPPOSITE SIDE OF ABSCESS AS WELL AS NO DYSKINEASIAS. BOTH THE NEW NEUROLOGICAL DEFICITS AND THE PREVIOUS TREMOR AND RIGIDITY IMPROVED AFTER SURGICAL DRAINAGE AND MEDICAL TREATMENT. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222274 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Other| R