BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3351050 · Received September 16, 2013

    Report

    Report Number
    3004209178-2013-16347
    Event Type
    Injury
    Date Received
    September 16, 2013
    Report Date
    August 22, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: 2013-(B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID 3387S-40, LOT# V103455, IMPLANTED: 2008-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3387S-40, LOT# V101646, IMPLANTED: 2008-(B)(6), (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT USUALLY HAD TROUBLE MOVING AROUND BUT RECENTLY IT SEEMED AS THOUGH IT WAS TAKING HER LONGER. THE REPORTER STATED THAT THE DEVICES WERE ON AND OK ON BOTH SIDES. IT WAS NOTED THAT THE PATIENT HAD BEEN EXPERIENCING SOME DEMENTIA AND WAS DIRECTED TO TAKE AN ADDITIONAL ½ PILL EVERY DAY. THE REPORTER STATED THAT THE PATIENT HAD THE DEVICE CHECKED TWO WEEKS PRIOR TO THIS REPORT AND WAS TOLD EVERYTHING WAS WORKING AS NORMAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFERENCE MANUFACTURING REPORT # 3004209178-2013-16346.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465440 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention