BEUDAMED
    FDA Adverse Event Other Summary report: N

    STOCKERT 70 RF ABLATION GENERATOR

    MDR report key: 517794 · Received March 25, 2004

    Report

    Report Number
    2020638-2004-00011
    Event Type
    Other
    Date Received
    March 25, 2004
    Date of Event
    June 3, 2003
    Report Date
    June 3, 2003
    Manufacturer
    STOCKERT GMBH
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER REMOVAL OF THE INDIFFERENT ELECTRODE PAD, REDNESS OR A FIRST DEGREE BURN AT THE SITE OF INDIFFERENT ELECTRODE PAD PLACEMENT WAS NOTED. DURING THE ABLATION PROCEDURE THE PT WAS MOVING AND IT IS POSSIBLE THE INDIFFERENT PAD WAS LOOSENED. IT IS POSSIBLE THAT THE INDIFFERENT ELECTRODE PAD WAS DRY OR BAD. PLEASE ALSO CHECK THE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STOCKERT 70 RF ABLATION GENERATOR RADIOFREQUENCY ABLATION GENERATOR LPB STOCKERT GMBH STOCKERT O RF GEN. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other CONMED INDIFFERENT ELECTRODE PAD 2003.