BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3250496 · Received July 26, 2013

    Report

    Report Number
    3004209178-2013-12367
    Event Type
    Injury
    Date Received
    July 26, 2013
    Report Date
    July 5, 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

    CONCOMITANT PRODUCTS: PRODUCT ID 3387S-40, LOT# V530092, PRODUCT TYPE LEAD; PRODUCT ID 37085-60, SERIAL# (B)(4), PRODUCT TYPE EXTENSION; PRODUCT ID 37601, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3387-40, LOT# L75840, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL# (B)(4), PRODUCT TYPE EXTENSION; PRODUCT ID 64001, LOT# N251196, PRODUCT TYPE ADAPTER; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STARTING AROUND (B)(6) 2011 PATIENT STARTED TO HAVE PERSISTING, EXCRUCIATING SHOCKS LASTING UP TO 30 SECONDS. IT WAS NOTED THAT SOMETIMES THE SURGING/SHOCKS WERE SO STRONG THEY WOULD IMMOBILIZE THE PATIENT. IT WAS NOTED THAT THE SURGING HAD SEEMED TO CORRELATE WITH CHANGING HEALTH CARE PROFESSIONALS. SHOCKING DID NOT SEEM TO BE MOVEMENT RELATED BUT RANDOM. 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
    350081 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Disability