BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ACTIVA

    MDR report key: 2020213 · Received March 9, 2011

    Report

    Report Number
    2020213
    Event Type
    Injury
    Date Received
    March 9, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 9, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    MHY
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT HAD BILATERAL IMPLANTATION OF MEDTRONIC DBS FOR DYSTONIA. SHE HAD ENTIRE REMOVAL OF PREVIOUS DBS SYSTEM. ON (B)(6) 2011, SHE WAS TAKEN BACK TO THE OPERATING ROOM TO REVISE HER DBS PULSE GENERATOR, DUE TO WORSENING DYSTONIA OF THE LEFT SIDE AND EXTREMELY HIGH IMPEDANCE IN THE RIGHT LEAD. RIGHT EXTENSION LEAD WAS DISCONNECTED FROM PULSE GENERATOR. IT WAS THEN CLEANED OFF, REINSERTED AND RE-SECURED. AT THIS TIME LEAD IMPEDANCE WAS RECHECKED AND NOTED TO BE NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ACTIVA MEDTRONIC DBS MHY MEDTRONIC RC37612 (LEADS) V603771

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other FLUOXETINE 20MG ONCE DAILY| CLONAZEPAM 1MG TWICE DAILY| GENERAL ANESTHESIA