BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2638836 · Received July 3, 2012

    Report

    Report Number
    3004209178-2012-05166
    Event Type
    Injury
    Date Received
    July 3, 2012
    Report Date
    June 6, 2012
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37642 SERIAL# (B)(4) PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37085-40 SERIAL# (B)(4) IMPLANTED: 2010-(B)(6) EXPLANTED: PRODUCT TYPE EXTENSION PRODUCT ID 37085-40 SERIAL# (B)(4) IMPLANTED: 2010-(B)(6) EXPLANTED: PRODUCT TYPE EXTENSION PRODUCT ID 3387S-40 LOT# V230077 IMPLANTED: 2009-(B)(6) EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID 3387S-40 LOT# V230077 IMPLANTED: 2009-(B)(6) EXPLANTED: PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEVER RECEIVED THERAPEUTIC EFFECT SINCE IMPLANT AND IT WAS NOTED THAT THERE WAS AN OPEN CIRCUIT. AFTER AN IMPEDANCE CHECK WAS DONE, NO OPEN CIRCUITS WERE FOUND. ADDITIONAL INFORMATION RECEIVED REPORTED THAT AN MRI WAS PERFORMED. THE EXISTING LEADS WERE REMOVED AND THE PATIENT WAS RE-IMPLANTED WITH NEW LEADS. THE PATIENT WAS DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention