BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTIVA

    MDR report key: 2895232 · Received January 3, 2013

    Report

    Report Number
    3007566237-2013-00024
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 10, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    KNS
    PMA / PMN Number
    K052413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE HANDPIECE DISPLAYED ERROR #14. THIS INDICATED THE HANDPIECE NEEDED TO BE REPLACED. THE PROCEDURE HAD TO BE RESCHEDULED BECAUSE THERE WAS NOT AN EXTRA AVAILABLE HANDPIECE TO USE. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2936 PROSTIVA UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS MEDTRONIC NEUROMODULATION 8929 119761

    Patients

    Seq Age Sex Outcome Treatment
    1 Other