BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4792212 · Received May 22, 2015

    Report

    Report Number
    3007566237-2015-01407
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    September 9, 2013
    Report Date
    May 5, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    CHOPRA, A., ABULSEOUD, O.A., SAMPSON, S., LEE, K.H., KLASSEN, B.T., FIELDS, J.A., MATSUMOTO, J.Y., ADAMS, A.C., STOPPEL, C.J., GESKE, J.R., FRYE, M.A. MOOD STABILITY IN PARKINSON DISEASE FOLLOWING DEEP BRAIN STIMULATION: A 6-MONTH PROSPECTIVE FOLLOW-UP STUDY. PSYCHOSOMATICS. 2014;55(5):478-484. SUMMARY: DEEP BRAIN STIMULATION FOR PARKINSON DISEASE HAS BEEN ASSOCIATED WITH PSYCHIATRIC ADVERSE EFFECTS INCLUDING ANXIETY, DEPRESSION, MANIA, PSYCHOSIS, AND SUICIDE. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE SAFETY OF DEEP BRAIN STIMULATION IN A LARGE PARKINSON DISEASE CLINICAL PRACTICE. PATIENTS APPROVED FOR SURGERY BY THE (B)6) PARTICIPATED IN A 6-MONTH PROSPECTIVE NATURALISTIC FOLLOW-UP STUDY. IN ADDITION TO THE UNIFIED PARKINSON'S DISEASE RATING SCALE, STABILITY AND PSYCHIATRIC SAFETY WERE MEASURED USING THE BECK DEPRESSION INVENTORY, HAMILTON DEPRESSION RATING SCALE, AND YOUNG MANIA RATING SCALE. OUTCOMES WERE COMPARED IN PATIENTS WITH PARKINSON DISEASE WHO HAD A PSYCHIATRIC HISTORY TO THOSE WITH NO CO-MORBID PSYCHIATRIC HISTORY. THE STUDY WAS COMPLETED BY 49 OF 54 PATIENTS. STATISTICALLY SIGNIFICANT 6-MONTH BASELINE TO END-POINT IMPROVEMENT WAS FOUND IN MOTOR AND MOOD SCALES. NO SIGNIFICANT DIFFERENCES WERE FOUND IN PSYCHIATRIC OUTCOMES BASED ON THE PRESENCE OR ABSENCE OF PSYCHIATRIC COMORBIDITY. OUR STUDY SUGGESTS THAT PATIENTS WITH PARKINSON DISEASE WHO HAVE A HISTORY OF PSYCHIATRIC CO-MORBIDITY CAN SAFELY RESPOND TO DEEP BRAIN STIMULATION WITH NO GREATER RISK OF PSYCHIATRIC ADVERSE EFFECT OCCURRENCE. A MULTIDISCIPLINARY TEAM APPROACH, INCLUDING CAREFUL PSYCHIATRIC SCREENING ENSURING MOOD STABILIZATION AND PSYCHIATRIC FOLLOW-UP, SHOULD BE VIEWED AS STANDARD OF CARE TO OPTIMIZE THE PSYCHIATRIC OUTCOME IN THE COURSE OF DEEP BRAIN STIMULATION TREATMENT. REPORTED EVENTS: ONE PATIENT WITH BILATERAL DEEP BRAIN STIMULATION (DBS) FOR PARKINSON¿S DISEASE EXPERIENCED MANIA WITH PSYCHOTIC FEATURES AND REQUIRED PSYCHIATRIC HOSPITALIZATION AS A RESULT. IT WAS NOTED THAT THE PATIENT HAD NO COMORBIDITY PRIOR TO IMPLANT. THE SOURCE LITERATURE DID NOT INCLUDE ANY SPECIFIC DEVICE INFORMATION. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335823 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization