BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3200243 · Received July 1, 2013

    Report

    Report Number
    3007566237-2013-02170
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    June 27, 2012
    Report Date
    June 25, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. (B)(4).

    Description of Event or Problem · 1

    LEFAUCHEUR, R., DERREY, S., BORDEN, A., WALLON, D., OZKUL, O., GERARDIN, E., MALTETE, D. POST-OPERATIVE EDEMA SURROUNDING THE ELECTRODE: AN UNUSUAL COMPLICATION OF DEEP BRAIN STIMULATION. BRAIN STIMULATION. 2013;6(3):459-460. DOI: 10.1016/J.BRS.2012.05.012. SUMMARY: A (B)(6) MAN WITH ADVANCED PARKINSON¿S DISEASE (PD) WAS REFERRED FOR CONTINUOUS BILATERAL HIGH-FREQUENCY STIMULATION OF THE SUBTHALAMIC NUCLEUS (STN). UNFORTUNATELY, DURING THE IMPLEMENTATION OF THE STEREOTACTIC FRAME, THE PINS FROM THE HEADHOLDER PERFORATED THE RIGHT TEMPORAL BONE AND PROVOKED A RIGHT ACUTE SUBDURAL HEMATOMA. SIX MONTHS LATER, IT WAS DECIDED TO PERFORM THE ENTIRE PROCEDURE UNDER GENERALIZED ANESTHESIA. TEN DAYS AFTER SURGERY, THE PATIENT DEVELOPED ACUTE CONFUSION WITH PREDOMINANT BEHAVIORAL TROUBLES AND HEADACHES. REPEATED CT SCAN REVEALED A RIGHT CORTICAL AND SUBCORTICAL HYPODENSITY SURROUNDING THE RIGHT LEAD WITHOUT ENHANCEMENT WE INTRODUCED ORAL CORTICOSTEROIDS AT 1 MG/KG/DAY FOR ONE WEEK. BOTH CLINICAL EXAMINATION AND RADIOLOGICAL IMAGING DRAMATICALLY IMPROVED AFTER THREE WEEKS. REPORTED EVENT: PATIENT EXPERIENCED RIGHT ACUTE SUBDURAL HEMATOMA DURING IMPLEMENTATION OF THE STEREOTACTIC FRAME WHEN PINS FROM THE HEADHOLDER PERFORATED THE RIGHT TEMPORAL BONE. IMPLANT PROCEDURE WAS POSTPONED A FEW MONTHS. THE SUBDURAL HEMATOMA SPONTANEOUSLY RESOLVED WITHOUT SEQUELAE. 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
    300031 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_NXFRAME_ACC

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Other