BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTIVA

    MDR report key: 1842680 · Received September 3, 2010

    Report

    Report Number
    3007566237-2010-06759
    Event Type
    Injury
    Date Received
    September 3, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 3, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    KNS
    PMA / PMN Number
    K052413
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN THE HAND PIECE WAS PROPERLY CONNECTED TO THE GENERATOR AND THE POWER BUTTON WAS PRESSED, NO THERAPY WAS DELIVERED. IMPEDANCES MEASUREMENTS DID NOT REVEAL ANY ABNORMALITIES. THE PHYSICIAN REPLACED THE HAND PIECE AND STILL HAD NO SUCCESS. THE PROCEDURE WAS SUSPENDED. NO PT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTIVA KNS MEDTRONIC NEUROMODULATION 8930 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention