BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2558028 · Received May 3, 2012

    Report

    Report Number
    6000153-2012-00104
    Event Type
    Malfunction
    Date Received
    May 3, 2012
    Date of Event
    April 5, 2012
    Report Date
    April 5, 2012
    Manufacturer
    NEURO - VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF LEAD MODEL 3389S-40, LOT # V860237 SHOWED THAT THE ELECTRODES WERE MISALIGNED AND THE DISTAL TIP WAS BENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE DOCTOR OPENED THE LEAD, THE TIP WAS BENT. THE IMPLANT WAS COMPLETED WITH A NEW GOOD LEAD. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR