BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 5813426 · Received July 21, 2016

    Report

    Report Number
    3007566237-2016-02705
    Event Type
    Death
    Date Received
    July 21, 2016
    Date of Event
    April 11, 2005
    Report Date
    July 21, 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 IS THE GENDER OF THE MAJORITY OF PATIENTS REPORTED IN THE ARTICLE AS THE ACTUAL GENDERS OF PATIENTS INVOLVED WAS NOT PROVIDED. DATE OF EVENT. PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF ONE OF THE SYSTEMS INVOLVED IN THE REPORTED EVENTS; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. 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

    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.

    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 WITHOUT PATIENT IDENTIFIERS: 1 PATIENT WITH BILATERAL SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS) FOR PARKINSON'S DISEASE (PD) COMMITTED SUICIDE. ONE (1) PATIENT WITH BILATERAL STN DBS FOR PD DIED FROM SPONTANEOUS CEREBRAL BLEEDING OF UNKNOWN CAUSE FOUR YEARS AFTER NEUROSURGERY. FOUR (4) PATIENTS WITH BILATERAL STN DBS FOR PD EXPERIENCED A SUICIDE ATTEMPT RELATED TO MEDICAL TREATMENT, STN STIMULATION, OR PROGRESSION OF THE DISEASE. THIS WAS NOTED TO BE A TRANSIENT EFFECT WHICH WAS SUCCESSFULLY TREATED DURING THE WEEKS AND MONTHS FOLLOWING NEUROSURGERY. ONE (1) PATIENT WITH BILATERAL STN DBS FOR PD EXPERIENCED A TRANSIENT INFECTION OF THE STIMULATOR RELATED TO THE NEUROSURGERY AND DEVICE, WHICH WAS SUCCESSFULLY TREATED DURING THE WEEKS AND MONTHS FOLLOWING NEUROSURGERY. INFECTION OF THE LEFT STIMULATOR LED TO UNILATERAL EXPLANTATION BEFORE THE 60 MONTH ASSESSMENT. TWO (2) PATIENTS WITH BILATERAL STN DBS FOR PD REQUIRED REPOSITIONING OF THE ELECTRODES IN THE PERI-OPERATIVE PERIOD DUE TO INITIALLY U NSATISFACTORY CLINICAL RESULTS. THIS WAS SUCCESSFULLY TREATED DURING THE WEEKS AND MONTHS FOLLOWING NEUROSURGERY; THE "POORLY PLACED" LEADS WERE SUCCESSFULLY REPLACED. ONE (1) PATIENT WITH BILATERAL STNDBD FOR PD REQUIRED THE RIGHT LEAD BE REIMPLANTED DUE TO AN ACCIDENTAL DISCONNECTION. THIS WAS SUCCESSFULLY TREATED DURING THE WEEKS AND MONTHS FOLLOWING NEUROSURGERY. SIX (6) PATIENTS WITH BILATERAL STN DBS FOR PD EXPERIENCED TRANSIENT DELIRIUM RELATED TO THE NEUROSURGERY AND DEVICE WHICH WAS SUCCESSFULLY TREATED DURING THE WEEKS AND MONTHS FOLLOWING NEUROSURGERY. SIX (6) PATIENTS WITH BILATERAL STN DBS FOR PD EXPERIENCED TRANSIENT HALLUCINATIONS RELATED TO MEDICAL TREATMENT, STN STIMULATION, OR PROGRESSION OF THE DISEASE WHICH WAS SUCCESSFULLY TREATED DURING THE WEEKS AND MONTHS FOLLOWING NEUROSURGERY. FOUR (4) PATIENTS WITH BILATERAL STN DBS FOR PD EXPERIENCED TRANSIENT PSYCHOSIS RELATED TO MEDICAL TREATMENT, STN STIMULATION, OR PROGRESSION OF THE DISEASE WHICH WAS SUCCESSFULLY TREATED DURING THE WEEKS AND MONTHS FOLLOWING NEUROSURGERY. EIGHT (8) PATIENTS WITH BILATERAL STN DBS FOR PD EXPERIENCED PERMANENT DISABLING DYSKINESIAS RELATED TO MEDICAL TREATMENT, STN STIMULATION, OR PROGRESSION OF THE DISEASE. THE FOLLOWING DEVICE SPECIFICS WERE PROVIDED: LEAD MODEL 3389-28, PROGRAMMER MODEL 7532, AND IMPLANTABLE NEUROSTIMULATORS ITREL II (37 PATIENTS) AND SOLETRA (15 PATIENTS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464716 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L| O| R