BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 5761327 · Received June 30, 2016

    Report

    Report Number
    3004209178-2016-13242
    Event Type
    Malfunction
    Date Received
    June 30, 2016
    Date of Event
    May 29, 2016
    Report Date
    June 30, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIM ULATOR (INS) FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THE LEADS WERE RE-NUMBERED AFTER THE REPLACEMENT AND NOW ELECTRODES 1 <(>&<)>2 CORRELATE TO 9 <(>&<)> 10 IN THE CURRENTLY CONFIGURED SYSTEM. AN IMPEDANCE MEASUREMENT WAS TAKEN WITH THE FOLLOWING MEASUREMENTS: C/8 972, C/9 786, C/10 556, C/11 556, 8/9 1094, 8/10 1141, 8/11 1149, 9/10 805, 9/11 817 AND 10/11 87 OHMS. WHEN THE PATIENT WAS USING HER GROUP ON 9<(>&<)>10 CURRENTLY, THEY FELT AN INTERMITTENT JOLTING SENSATION SO THEY DELETED THAT GROUP ALTOGETHER. THE PATIENT WAS CURRENTLY PROGRAMMED ON 8+ 9- AND WAS GETTING ONLY PARTIAL SYMPTOM RELIEF. THE SYSTEM WAS FINE 2 WEEKS PRIOR TO REPORT AND 3 DAYS LATER WAS WHEN THE PATIENT STARTED TO FEEL ISSUES. ADDITIONAL INFORMATION RECEIVED 8 DAYS LATER FROM THE HCP REPORTED DIAGNOSTICS INCLUDED DEEP BRAIN STIMULATOR (DBS) INTERROGATION. THERAPY AND ELECTRODE IMPEDANCES WERE DISCUSSED WITH TECHNICAL SUPPORT AND THE CAREGIVER BY TELEPHONE. ACTIONS/INTERVENTIONS INCLUDED THE PATIENT WAS SEEN BY THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415685 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR