BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSTIVA

    MDR report key: 2954097 · Received April 20, 2007

    Report

    Report Number
    2649622-2007-03566
    Event Type
    Malfunction
    Date Received
    April 20, 2007
    Date of Event
    March 22, 2007
    Report Date
    March 22, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
    Product Code
    KNS
    PMA / PMN Number
    K052413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) TO DATE THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC FOR EVAL. IF FURTHER INFO IS RECEIVED OR THE DEVICE RETURNED, A FOLLOW-UP MEDWATCH REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HCP THAT DURING A TRANSURETHRAL NEEDLE ABLATION OF THE PROSTATE THE NEEDLES ON THE PROSTIVA HANDPIECE WOULD NOT RETRACT. NO SERIOUS INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTIVA KNS MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA 8929 V018202

    Patients

    Seq Age Sex Outcome Treatment
    1