BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTIVA

    MDR report key: 1001552 · Received February 21, 2008

    Report

    Report Number
    6000153-2008-00839
    Event Type
    Injury
    Date Received
    February 21, 2008
    Report Date
    January 22, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    KNS
    PMA / PMN Number
    K052413
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP MEDWATCH REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE AND/OR WHEN ADD'L INFO IS RECEIVED FROM THE HCP.

    Description of Event or Problem · 1

    THE HCP REPORTED THAT DURING A TRANSURETHRAL NEEDLE ABLATION OF THE PROSTATE THE NEEDLES ON THE PROSTIVA HANDPIECE FAILED TO RETRACT. THE DEVICE WAS REMOVED FROM THE PT WITH THE NEEDLES STILL DEPLOYED. THE PT EXPERIENCED SIGNIFICANT BLEEDING FROM HIS URETHRA AND A CATHETER WAS INSERTED TO ALLOW THE URETHRA TO HEAL. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTIVA KNS MEDTRONIC PUERTO RICO OPERATIONS CO. 8929 07J204V

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention