BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5535679 · Received March 30, 2016

    Report

    Report Number
    3007566237-2016-01531
    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. THE DEVICE WAS USED FOR AN OFF LABEL INDICATION AS IT WAS IMPLANTED FOR TARDIVE DYSKINESIA. SECTION INFORMATION REFERENCES THE MAIN COMPONENT OF ONE OF THE SYSTEMS INVOLVED IN THE REPORTED EVENTS; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_UNKNOWN_EXT, PRODUCT TYPE: EXTENSION.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 1: (B)(6) FEMALE PATIENT WITH DEEP BRAIN STIMULATION (DBS) FOR TARDIVE DYSKINESIA (TD) COMPLAINED OF PAIN RELATED TO CONNECTION CABLE TRACTION WITHIN ONE YEAR OF IMPLANT. AFTER THE STIMULATOR HAD BEEN ATTACHED TO THE CLAVICLE, THE PAIN DISAPPEARED. THIS PAINFUL TRACTION EXERTED BY THE CABLE CONNECTION WAS NOTED TO BE STRONGLY RELATED TO THE EQUIPMENT AND REQUIRED RE-INTERVENTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CORRESPONDING AUTHOR REGARDING EVENT DATE, PRODUCT INFORMATION, AND CAUSES/FACTORS, BUT IT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE FOLLOWING DEVICE INFORMATION WAS INCLUDED IN THE ARTICLE: LEAD MODEL 3387 AND IMPLANTABLE NEUROSTIMULATORS ITREL II MODEL 7424 AND/OR KINETRA MODEL 7428 SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191413 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR Required Intervention