BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSTIVA

    MDR report key: 1231241 · Received November 13, 2008

    Report

    Report Number
    6000153-2008-07444
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 15, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    KNS
    PMA / PMN Number
    K052413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRANSURETHRAL NEEDLE ABLATION OF THE PROSTATE, THE GENERATOR FAILED. PRIOR TO THE PROCEDURE, THE GENERATOR WAS TESTED AND IT GAVE AN ERROR CODE INDICATING IT FAILED ITS SELF-TEST FOR RF ACCURACY. THE GENERATOR WAS TURNED OFF FOR 5 SECONDS AND TURNED BACK ON AFTER WHICH WAS A SUCCESSFUL SELF-TEST. THE PROCEDURE WAS INITIATED AND AT THE SECOND LESION, THE GENERATOR BLACKED OUT AND TURNED ITSELF OFF. IT WAS NOTED THAT THE URETHRAL TEMP HAD BEEN INCREASING FAST. THE GENERATOR COULD NOT BE TURNED ON AND IT WAS DECIDED TO ABORT THE CASE. NO INJURY TO THE PT WAS REPORTED.

    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 EXPLANTED:| GENERATOR: MODEL 8930| IMPLANTED: