BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3030977 · Received April 2, 2013

    Report

    Report Number
    6000153-2013-00053
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    January 25, 2013
    Report Date
    March 11, 2013
    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 AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE LEAD MODEL 3889, LOT # VA03040 SHOWED NO ANOMALIES. ANALYSIS OF THE STYLET ACCESSORY SHOWED THAT IT WAS BENT (NEW OUT OF THE BOX) NEAR THE DISTAL TIP OF THE LEAD. IT WAS NOTED THAT STRAIGHT TIP STYLETS ARE INSERTED INTO THE LEAD WHEN MANUFACTURED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD WAS FOUND BENT AT THE OPENING OF THE PACKAGE. IT WAS NOTED THAT THE LEAD WAS NEVER IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134659 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY NEURO - VILLALBA 3389-28 VA03040

    Patients

    Seq Age Sex Outcome Treatment
    1