BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTIVA

    MDR report key: 1190163 · Received October 3, 2008

    Report

    Report Number
    6000153-2008-06333
    Event Type
    Injury
    Date Received
    October 3, 2008
    Report Date
    September 5, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    KNS
    PMA / PMN Number
    K052413
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED TRANSURETHRAL NEEDLE ABLATION OF THE PROSTATE IN 2007, AND SINCE THEN HE WAS EXPERIENCED INCONTINENCE, LOSS OF SEXUAL SENSATION IN HIS PENIS, AND PREMATURE EJACULATION. FURTHER INFORMATION IS BEING REQUESTED AT THIS TIME. THE PHYSICIAN INFORMATION WAS NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention