BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3201136 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-02176
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    July 9, 2011
    Report Date
    June 25, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    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. CONCOMITANT PRODUCT: PRODUCT ID 3389, LOT # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID 3389, LOT # UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD DBS SURGERY ON (B)(6) 2011 AND THE OEDEMA OCCURRED TEN DAYS LATER. THE REPORTER STATED THAT THE PATIENT WAS HOSPITALIZED AND CORTICOSTEROIDS WERE INTRODUCED DURING ONE WEEK. THE PATIENT REPORTEDLY DRAMATICALLY IMPROVED IN A FEW DAYS. IT WAS NOTED THAT THERE WAS NO OBSERVED DEVICE DYSFUNCTION AND THE PATIENT¿S STATUS WAS NORMAL FOLLOWING THE EVENT.

    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. 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 DEVELOPED ACUTE CONFUSION WITH PREDOMINANT BEHAVIORAL TROUBLES AND HEADACHES 10 DAYS AFTER SURGERY. NEUROLOGICAL EXAMINATION FOUND MODERATE LEFT HEMICORPORAL AKINETORIGID SYNDROME AND AN ISOLATED LEFT BABINSKI¿S SIGN. REPEATED CT SCAN REVEALED A RIGHT CORTICAL AND SUBCORTICAL HYPODENSITY SURROUNDING THE RIGHT LEAD WITHOUT ENHANCEMENT (CF. FIG.1B). MOREOVER, BRAIN MRI REVEALED HYPERINTENSITY IN FLAIR, T2, T2* AND T1 WEIGHTED SEQUENCES WITHOUT GADOLINIUM ENHANCEMENT. STANDARD LABORATORY VALUES WERE NORMAL. SINCE THERE WAS NO EVIDENCE OF INFECTIOUS OR VASCULAR PROCESSES, WE ASSUMED THAT THIS HYPERSIGNAL WAS POST-OPERATIVE EDEMA SURROUNDING THE RIGHT ELECTRODE. WE INTRODUCED ORAL CORTICOSTEROIDS AT 1 MG/KG/DAY FOR ONE WEEK. BOTH CLINICAL EXAMINATION AND RADIOLOGICAL IMAGING DRAMATICALLY IMPROVED AFTER THREE WEEKS. SIX MONTHS AFTER DBS, A SIGNIFICANT MEAN IMPROVEMENT OF 55% IN THE MOTOR SCORE WAS RECORDED WHEN COMPARING THE OFF-MEDICATION, ON-STIMULATION CONDITION WITH BASELINE OFF MEDICATION CONDITION. 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
    303232 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization| O