BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2822688 · Received November 7, 2012

    Report

    Report Number
    6000153-2012-00221
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 8, 2012
    Manufacturer
    NEURO - VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR DURING IMPLANT TRIED TO SECURE THE TWIST LOCK BARREL CONNECTOR TO THE DISTAL TIP OF THE ELECTRODE BUT FELT LIKE SOMETHING WAS KEEPING IT FROM ATTACHING PROPERLY. AFTER TRYING TO CONNECT THE BARREL LOCK A FEW TIMES IT WAS NOTICED THAT THE LEAD HAD MIGRATED INFERIORLY. THE LEAD WAS EXTRACTED AND A NEW LEAD AND BARREL CONNECTOR WERE OPENED AND USED WITHOUT ANY PROBLEMS. A TEST STIMULATION WAS DONE AND THE PATIENT NOTICED EFFICACY WITH REDUCED TREMOR. IT WAS NOTED THAT THE PATIENT'S SYMPTOM WAS NAUSEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY NEURO - VILLALBA 3389S-40 VA02HC7

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR