BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3420760 · Received October 21, 2013

    Report

    Report Number
    3004209178-2013-19378
    Event Type
    Malfunction
    Date Received
    October 21, 2013
    Date of Event
    September 27, 2013
    Report Date
    October 1, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION; PRODUCT ID 3389S-40, LOT# V320477, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 3389S-40, LOT# V320477, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4). THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. THE THERAPY THE DEVICE WAS USED FOR WAS MRU.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN X-RAY DONE ON HER LEFT HAND ON (B)(6) 2013. IT WAS NOTED THAT THE REASON FOR THE X-RAY WAS NOT RELATED TO THE PATIENT¿S THERAPY. IT WAS FURTHER NOTED THAT SINCE THEN THE PATIENT HAD HEADACHES ON THE RIGHT SIDE. ADDITIONAL INFORMATION REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539583 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR