BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5535583 · Received March 30, 2016

    Report

    Report Number
    3007566237-2016-01529
    Event Type
    Injury
    Date Received
    March 30, 2016
    Date of Event
    January 20, 2016
    Report Date
    March 30, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF ONE OF THE SYSTEMS INVOLVED IN THE REPORTED EVENTS; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3387, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    POUCLET-COURTEMANCHE H., ROUAUD, T., THOBOIS, S., NGUYEN, J-M., BREFEL- COURBON, C., CHEREAU, I., CUNY, E., DEROST, P., EUSEBIO, A., GUEHL, D., LAURENCIN, C., MERTENS, P., ORY-MAGNE, F., RAOUL, S., REGIS, J., ULLA, M., WITJAS, T., BURBAUD, P., RASCOL, O., DAMIER, P. LONG-TERM EFFICACY AND TOLERABILITY OF BILATERAL PALLIDAL STIMULATION TO TREAT TARDIVE DYSKINESIA. NEUROLOGY. 2016. 86:1¿9. DOI: 10.10.1212/WNL.0000000000002370. SUMMARY: TO CONFIRM THE EFFICACY AND SAFETY OF DEEP BRAIN STIMULATION (DBS) OF THE INTERNAL PART OF THE GLOBUS PALLIDUS IN IMPROVING SEVERE TARDIVE DYSKINESIA (TD). REPORTED EVENTS: PATIENT 5: ONE (B)(6) MALE PATIENT WITH DEEP BRAIN STIMULATION (DBS) FOR TARDIVE DYSKINESIA (TD) DID NOT BENEFIT FROM STIMULATION AS THE LEAD WAS IN TOO LATERAL AND TOO ANTERIOR A POSITION. THIS WAS NOTED TO BE AN INITIAL MISPLACEMENT OF THE LEAD. THE LEAD WAS REPOSITIONED TWO MONTHS AFTER THE INITIAL SURGERY, WITH GOOD RESULTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CORRESPONDING AUTHOR REGARDING EVENT DATE, PRODUCT INFORMATION, TROUBLESHOOTING, AND DIAGNOSTICS, BUT IT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICE INFORMATION INCLUDED IN THE ARTICLE: LEAD MODEL 3387 AND IMPLANTABLE NEUROSTIMULATORS ITREL II MODEL 7424 OR KINETRA MODEL 7428.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191577 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention