BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSTIVA

    MDR report key: 2183683 · Received July 8, 2011

    Report

    Report Number
    3007566237-2011-05231
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    April 1, 2011
    Report Date
    June 15, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    KNS
    PMA / PMN Number
    K052413
    Removal / Correction Number
    Z-1060-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE HAND PIECE MODEL 8929 FOUND THE SCOPE TUBE WAS PUSHED THROUGH THE FRONT STOP, WHICH DAMAGED THE SEAL. THE BINDING NEEDLES/SHEATHS AT THE FRONT STOP WERE DAMAGED, WHICH EVENTUALLY BROKE THE NEEDLE BLOCK POSTS. THE DEVICE WAS RETURNED WITH BOTH NEEDLES DEPLOYED BY 8 CM. EIGHT LESIONS WERE STARTED WITH FIVE ABORTED. TOTAL RF ON TIME WAS 9:53 (MIN/SEC). NO HARDWARE ERRORS WERE FOUND. THE DEVICE PASSED THE TEST FIXTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLES REPEATEDLY FAILED TO DEPLOY COMPLETELY. THE PROBE NEEDLE DEPLOYED PRE-TREATMENT, BUT THE HANDLE WAS SOMEWHAT DIFFICULT TO SQUEEZE. DURING THE SECOND TREATMENT (AT 52 SECONDS) IMPEDANCE EXCEEDED TREATMENT PARAMETERS IN THE RIGHT NEEDLE AND TREATMENT AUTOMATICALLY STOPPED. REATTEMPTED WITH SIMILAR RESULTS. THE PROBE WAS REMOVED FROM THE PATIENT AND DEPLOYMENT WAS TESTED; THE NEEDLE WOULD ONLY PARTIALLY DEPLOY AND THE HANDLE WOULD NOT "CLICK" INTO PLACE SHOWING ALL BLUE THROUGH THE PORTAL ON THE SIDE OF THE DEVICE. THE NEEDLE LENGTH WAS CHANGED, AND DEPLOYMENT WAS RETESTED; HOWEVER, THIS RESULTS IN THE TRIGGER HANDLE MECHANISM COMPLETELY BREAKING OFF. DURING THE PROCEDURE, THE "CHECK HANDPIECE" ERROR CODE APPEARED. THE NEEDLES BEING USED AT THE TIME OF THE EVENT WERE SIZE 12. ANOTHER CARTRIDGE WAS OPENED AND THE PROCEDURE CONTINUED WITHOUT EVENT. NO INJURY WAS REPORTED. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTIVA KNS MEDTRONIC NEUROMODULATION 8929 20810

    Patients

    Seq Age Sex Outcome Treatment
    1