BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3251506 · Received July 29, 2013

    Report

    Report Number
    6000153-2013-00142
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 3, 2013
    Manufacturer
    NEURO - VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_STYLET_ACC, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD STYLET WAS BENT OUT OF THE PACKAGING ABOUT 1 CENTIMETER FROM THE DISTAL TIP OF THE LEAD. IT WAS NOTED THAT THIS CAUSED THE END OF THE LEAD NOT TO BE STRAIGHT. IT WAS NOTED THAT THE LEAD WAS NOT IMPLANTED AND ANOTHER LEAD WAS USED FOR THE CHRONIC IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353424 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY NEURO - VILLALBA 3389S-40 VA0A6SN

    Patients

    Seq Age Sex Outcome Treatment
    1