BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 6390887 · Received March 9, 2017

    Report

    Report Number
    3007566237-2017-00907
    Event Type
    Injury
    Date Received
    March 9, 2017
    Date of Event
    November 2, 2016
    Report Date
    March 9, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    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. 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

    KORDOWER JH, GOETZ CG, CHU Y, HALLIDAY GM, NICHOLSON DA, MUSIAL TF, MARMION DJ, STOESSL AJ, SOSSI V, FREEMAN TB, OLANOW CW. ROBUST GRAFT SURVIVAL AND NORMALIZED DOPAMINERGIC INNERVATION DO NOT OBLIGATE RECOVERY IN A PARKINSON DISEASE PATIENT. ANN NEUROL 2017; 81:46-57 DOI: 10.1002/ANA.24820 SUMMARY: THE MAIN GOAL OF DOPAMINE CELL REPLACEMENT THERAPY IN PARKINSON DISEASE (PD) IS TO PROVIDE CLINICAL BENEFIT MEDIATED BY GRAFT SURVIVAL WITH NIGROSTRIATAL REINNERVATION. THE AUTHORS REPORT A DICHOTOMY BETWEEN GRAFT STRUCTURE AND CLINICAL FUNCTION IN A PATIENT DYING 16 YEARS FOLLOWING FETAL NIGRAL GRAFTING. A (B)(6) LEVODOPA-RESPONSIVE WOMAN WITH PD RECEIVED BILATERAL PUTAMINAL FETAL MESENCEPHALIC GRAFTS AS PART OF AN NIH-SPONSORED DOUBLE-BLIND SHAM-CONTROLLED TRIAL. THE PATIENT NEVER EXPERIENCED CLINICAL BENEFIT, AND HER COURSE WAS COMPLICATED BY THE DEVELOPMENT OF GRAFT-RELATED DYSKINESIAS. FLUORODOPA POSITRON EMISSION TOMOGRAPHY DEMONSTRATED SIGNIFICANT INCREASES POSTGRAFTING BILATERALLY. SHE EXPERIENCED WORSENING OF PARKINSONISM WITH SEVERE DYSKINESIAS, AND UNDERWENT SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION 8 YEARS AFTER GRAFTING. SHE DIED 16 YEARS AFTER TRANSPLANTATION. REPORTED EVENTS: ONE FEMALE PATIENT UNDERWENT BILATERAL PUTAMINAL FETAL MESENCEPHALIC GRAFT IMPLANT FOR TREATMENT OF PARKINSON¿S DISEASE (PD) AT THE AGE OF (B)(6). THE PATIENT DID NOT EXPERIENCE CLINICAL BENEFIT AS A RESULT. IN 2007, EIGHT YEARS AFTER GRAFT IMPLANT, THE PATIENT UNDERWENT BILATERAL SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS) IMPLANT DUE TO WORSENING PARKINSONISM WITH SEVERE GRAFT-INDUCED DYSKINESIAS. THE AUTHORS STATED THAT MEDICAL RECORDS INDICATED SIGNIFICANT IMPROVEMENT IN MOTOR FUNCTION FOLLOWING DBS, PARTICULARLY WITH RESPECT TO PEAK DOSE DYSKINESIA. HOWEVER, IT WAS ALSO STATED THAT INITIALLY AFTER SURGERY, THE PATIENT WALKED WITH A WALKER, BUT PERSISTENT FREEZING AND GAIT IMPAIRMENT LED TO THE DECISION TO KEEP HER WHEELCHAIR BOUND EXCEPT FOR TRANSFERS. SHE NEEDED HELP WITH EATING AND DRESSING, AND DEVELOPED COGNITIVE IMPAIRMENT, SEVERE HYPOPHONIA, AND SWALLOWING DIFFICULTIES. NO SPECIFIC DEVICE INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173608 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Disability