BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROSTIVA

    MDR report key: 1002857 · Received February 25, 2008

    Report

    Report Number
    6000153-2008-00857
    Event Type
    Other
    Date Received
    February 25, 2008
    Report Date
    January 25, 2008
    Manufacturer
    MPROC, VILLALBA
    Product Code
    KNS
    PMA / PMN Number
    K052413
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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

    THE PT REPORTED THAT HE HAS BEEN EXPERIENCING RETROGRADE EJACULATION SINCE HIS PROSTIVA PROCEDURE APPROX ONE YR AGO. FURTHER INFO COULD NOT BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTIVA KNS MPROC, VILLALBA 8929 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other