BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2972312 · Received February 21, 2013

    Report

    Report Number
    3007566237-2013-00561
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 25, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    TOUSI, B., WILSON, K. FALLS RELATED TO ACCIDENTAL DEACTIVATION OF DEEP BRAIN STIMULATORS INPATIENTS WITH PARKINSON'S DISEASE LIVING IN LONG TERM CARE FACILITIES. JOURNAL OF THE AMERICAN MEDICAL DIRECTORS ASSOCIATION. 2013;AM.MED(1):58-59. DOI: 10.1016/J.JAMDA.2012.08.011. SUMMARY: THIS CASE SERIES HIGHLIGHTS THREE PATIENTS WITH PARKINSON'S DISEASE RESIDING AT NURSING HOME FACILITIES WHOSE DEEP BRAIN STIMULATORS WERE ACCIDENTALLY DEACTIVATED FOR VARYING LENGTHS OF TIME, WHICH WAS ASSOCIATED WITH AN INCREASE IN FALLS. IN ALL THREE CASES, NEITHER THE PATIENTS NOR THE CAREGIVERS WERE AWARE OF THE RANDOM DEACTIVATIONS/REACTIVATIONS. WE PROPOSE A SPECIFIC CARE PLAN FOR THESE PATIENTS THAT INCLUDES FURTHER EDUCATION OF CAREGIVERS REGARDING DEEP BRAIN STIMULATORS AND REGULAR CHECKS OF THE REVIEW DEVICE, ESPECIALLY WHEN THERE IS CONCERN ABOUT A PATIENT'S MOBILITY OR BALANCE THAT IS OUT OF CHARACTER. REPORTED EVENT: A 65 YEAR OLD MALE EXPERIENCED GRADUAL DECLINE IN COGNITION AND FUNCTION. THE LEFT IMPLANTABLE NEUROSTIMULATOR (INS) WAS FOUND TO BE OFF. THE INS HAD BEEN TURNED ON 55% OF THE TIME FOR A TOTAL OF 1815 HOURS. THE INS LISTED NO ACCIDENTAL ACTIVATION, WHICH SOMETIMES OCCUR WHEN THE INS TURNS OFF BUT NOT BACK ON AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77163 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR