BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STOCKERT 70 RF GENERATOR

    MDR report key: 3568158 · Received January 10, 2014

    Report

    Report Number
    9612355-2014-00002
    Event Type
    Malfunction
    Date Received
    January 10, 2014
    Date of Event
    December 19, 2013
    Report Date
    December 19, 2013
    Manufacturer
    STOCKERT GMBH
    Product Code
    DRF
    PMA / PMN Number
    P990071
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCT: EZ STEER THERMOCOOL SF NAV; MODEL# D-1313-05-S LOT # 15975638L; (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE TEMPERATURE DROPPED TO 2 DEGREE CELSIUS WITHOUT ANY ERROR MESSAGE AND CONTINUED TO ABLATE IN THIS TEMPERATURE. THE GENERATOR WAS IN POWER CONTROL MODE. CHANGING OUT THE CATHETER CABLE DID NOT RESOLVE THE ISSUE. THE CASE WAS COMPLETED BY CHANGING THE CATHETER WITHOUT ANY PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18686 STOCKERT 70 RF GENERATOR RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE DRF STOCKERT GMBH M-5463-01

    Patients

    Seq Age Sex Outcome Treatment
    1