BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5809003 · Received July 20, 2016

    Report

    Report Number
    3007566237-2016-02692
    Event Type
    Injury
    Date Received
    July 20, 2016
    Date of Event
    April 11, 2005
    Report Date
    July 20, 2016
    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

    DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. CONCOMITANT MEDICAL PRODUCTS: LEAD MODEL 3389-28; IMPLANTABLE NEUROSTIMULATORS ITREL II OR SOLETRA; PROGRAMMER MODEL 7532. 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

    SCHUPBACH, W.M.M., CHASTAN, N., WELTER, M.L., HOUETO, J.L., MESNAGE, V., BONNET, A.M., AGID, Y. STIMULATION OF THE SUBTHALAMIC NUCLEUS IN PARKINSON'S DISEASE: A 5 YEAR FOLLOW UP. JOURNAL OF NEUROLOGY, NEUROSURGERY, AND PSYCHIATRY. 2005. 76(12), 1640-4. DOI: 10 .1136/JNNP.2005.063206. SUMMARY: THE SHORT TERM BENEFITS OF BILATERAL STIMULATION OF THE SUBTHALAMIC NUCLEUS (STN) IN PATIENTS WITH ADVANCED LEVODOPA RESPONSIVE PARKINSON¿S DISEASE (PD) ARE WELL DOCUMENTED, BUT LONG TERM BENEFITS ARE STILL UNCERTAIN. THIS STUDY PROVIDES A 5 YEAR FOLLOW UP OF PD PATIENTS TREATED WITH STIMULATION OF THE STN. REPORTED EVENTS 2 MALE PATIENTS WITH BILATERAL STN DBS FOR PD EXPERIENCED UNEXPECTED TRANSIENT URINARY RETENTION DURING THE PERI-OPERATIVE PERIOD RELATED TO THE NEUROSURGERY AND DEVICE. THIS WAS SUCCESSFULLY TREATED DURING THE WEEKS AND MONTHS FOLLOWING NEUROSURGERY. THIS NECESSITATED TRANSURETHRAL RESECTION OF THE PROSTATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463985 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention