BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2665734 · Received July 23, 2012

    Report

    Report Number
    6000153-2012-00159
    Event Type
    Malfunction
    Date Received
    July 23, 2012
    Date of Event
    June 19, 2012
    Report Date
    June 25, 2012
    Manufacturer
    NEURO - VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD MODEL 3389-28 LOT UNKNOWN FOUND THE LEAD WAS BENT, NEW OUT OF THE BOX. THE DISTAL END OF THE LEAD WAS BENT. THERE WAS EXCESSIVE ADHESIVE AT THE DISTAL END. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SEE MFR. REP. # 6000153-2012-00157, 6000153-2012-00158, 6000153-2012-00160, AND 6000153-2012-00161.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISTAL TIP OF THE LEAD WAS ANOMALOUS. THERE WAS A SLIGHTLY CURVED BULGE AT THE DISTAL TIP OF THE LEAD. THE DIAMETER OF THE LEAD AT THE END WAS LARGER THAN ON THE REST OF THE LEAD. THE SURGEON HAD TO OPEN 7 BOXES TO FIND 2 NORMAL LEADS. THE 5 OTHER WERE ABNORMAL. THERE WAS NO PATIENT INJURY AND IT WAS REPORTED THAT THE PATIENT WAS FINE. SEE MFR REPORT # 6000153-2012-00157, 6000153-2012-00158.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY NEURO - VILLALBA 3389-28 V798529

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention