BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3031058 · Received April 2, 2013

    Report

    Report Number
    6000153-2013-00054
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    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

    (B)(4)

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_STIMLOC_ACC, PRODUCT TYPE ACCESSORY. ANALYSIS OF THE LEAD FOUND NO ANOMALIES. THE LEAD WAS RETURNED NEW AND IN STERILE TRAY, ONLY A VISUAL INSPECTION WAS PERFORMED. ANALYSIS OF THE SUPPORT CLIP FOUND NO ANOMALIES.

    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

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE ¿INSERTION¿ TOOL REFERRED TO WAS THE LEAD ANCHOR SUPPORT CLIP. THE LOCKING ENGAGEMENT WAS LOOSE AND UNSTABLE. IT WAS UNCLEAR IF A NEW LEAD WAS USED OR IF ONLY THE SUPPORT CLIP WAS REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DURING THE IMPLANT PROCEDURE TO IMPLANT THE LEAD COMPONENT OF THE IMPLANTABLE NEUROSTIMULATOR (INS), IT WAS OBSERVED THAT THE INSERTION TOOL FOR THE LOCKING DEVICE WAS LOCKED THE NOTCH BUT THE FIXATION WAS NOTED AS STILL ¿LOOSE¿. A NEW LEAD WAS THEN USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134020 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY NEURO - VILLALBA 3387S-40 VA00846

    Patients

    Seq Age Sex Outcome Treatment
    1