BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3232059 · Received July 17, 2013

    Report

    Report Number
    3004209178-2013-11903
    Event Type
    Injury
    Date Received
    July 17, 2013
    Report Date
    June 24, 2013
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3387S-40 LOT# V557335, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3387S-40 LOT# V741239, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 37085-60 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 37085-60 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE LEADS WERE REPOSITIONED AFTER THE PATIENT WAS IMPLANTED. THE REPORTER STATED THAT THE LEADS WERE NOT PLACED CORRECTLY OR THEY MOVED AND THEY WERE REPOSITIONED. IT WAS NOTED THAT THE PATIENT HAD TWO SURGERIES AND THE IMPLANTABLE NEUROSTIMULATOR AND EXTENSION WERE NOT DISTURBED, BUT A NEW RIGHT LEAD WAS PUT IN A BETTER PLACE AND THE OLD RIGHT LEAD WAS REMOVED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS IMPLANTED ONE PLACE, THE LEADS WERE NOT PLACED INCORRECTLY, SHE THEN WENT TO A DIFFERENT PLACE AND THEY RELOCATED THE LEADS. IT WAS NOTED THAT THIS CHANGED HER LIFE FROM BEING HOME BOUND TO BEING ABLE TO DRIVE A CAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331266 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention