BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 5100779 · Received September 24, 2015

    Report

    Report Number
    3004209178-2015-18619
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Date of Event
    August 30, 2015
    Report Date
    August 31, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389S-40, LOT# V884064, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3389S-40, LOT# V884064, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37085-40, SERIAL# (B)(4), IMPLANTED:(B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37085-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. (B)(4)

    Description of Event or Problem · 1

    A HEALTH CARE PROVIDER REPORTED THAT THE PATIENT HAD A LOSS OF THERAPY AND RETURNED OF SYMPTOMS. THE CHANGED IN THERAPY/SYMPTOMS WAS CONSIDERED SUDDEN. THE PATIENT WAS NOT RECEIVING THERAPEUTIC BENEFIT FROM THE DEEP BRAIN STIMULATOR. IT WAS ALSO NOTED THAT THE FALL COULD BE RELATED TO THE EVENT. THE IMPEDANCE MEASUREMENTS WERE TAKEN AND IT READ 1000-4600 OHMS ON LEFT SIDE AND RIGHT SIDE WAS WITHIN RANGE. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. THE PATIENT'S INDICATION FOR USE IS PARKINSON'S DUAL

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM HEALTH CARE PROVIDER ON 09/28/2015 REPORTED THAT THEY CHECKED THE IMPEDANCE AND EVERYTHING WAS FINE. THE STIMULATOR WAS WORKING WELL WHEN THE PATIENT WAS SEEN IN THE EMERGENCY ROOM. THE PATIENT WAS TO FOLLOW UP WITH HER NEUROLOGIST AS PRECAUTION. THE CAUSE OF PATIENT'S SYMPTOMS WAS UNKNOWN AT THIS TIME. IT MIGHT BE RELATED TO NORMAL DISEASE PROGRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631514 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR