BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5535640 · Received March 30, 2016

    Report

    Report Number
    3007566237-2016-01530
    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

    PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. PLEASE NOTE THAT THIS DEVICE WAS USED OFF LABEL AS IT WAS IMPLANTED TO TREAT TARDIVE DYSKINESIA. OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_STIMLOC_ACC, LOT# UNKNOWN, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3387, LOT# UNKNOWN, 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 19: ONE (B)(6)YEAR-OLD MALE PATIENT WITH DEEP BRAIN STIMULATION (DBS) FOR TARDIVE DYSKINESIA (TD) HAD THE LEFT LEAD SHIFTED 1.5CM UPWARDS AND REQUIRED THE LEAD TO BE REPOSITIONED 11 MONTHS AFTER THE INITIAL SURGERY. THIS DISPLACEMENT WAS NOTED TO BE LIKELY DUE TO FAILURE OF THE LEAD FIXATION TO THE SKULL. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CORRESPONDING AUTHOR REGARDING EVENT DATES, PRODUCT INFORMATION, SYMPTOMS, TROUBLESHOOTING, DIAGNOSTICS, AND PATIENT OUTCOME, BUT IT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE ARTICLE INCLUDED THE FOLLOWING DEVICE INFORMATION: LEAD MODEL 3387 AND IMPLANTABLE NEUROSTIMULATOR ITREL II MODEL 7424 OR KINETRA MODEL 7428.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190294 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Required Intervention