BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STOCKERT 70 RF GENERATOR

    MDR report key: 3303064 · Received August 22, 2013

    Report

    Report Number
    9612355-2013-00037
    Event Type
    Injury
    Date Received
    August 22, 2013
    Date of Event
    August 8, 2013
    Report Date
    August 8, 2013
    Manufacturer
    STOCKERT GMBH
    Product Code
    DRF
    PMA / PMN Number
    P990071
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4). IT WAS REPORTED THAT THE PATIENT SUFFERED A SECOND DEGREE SKIN BURN, DISCOVERED UNDER THE INDIFFERENT ELECTRODE AFTER AN AFIB ABLATION. STOCKERT IFU STATES THAT THE AREA OF PATCH APPLICATION MUST ALSO BE THOROUGHLY CLEANED, DRY, AND PREFERABLY SHAVED FOR OPTIMUM PLACEMENT AND GROUNDING OF THE PATCH TO REDUCE THE LIKELIHOOD OF SKIN BURN. IT WAS REPORTED THAT DUE TO PATIENT PERSPIRATION, THE ADHESION OF THE PATCH MAY HAVE BEEN COMPROMISED, HOWEVER, FURTHER DETAILS HAVE NOT BEEN PROVIDED BY THE FACILITY. THE FACILITY INDICATED THAT THE EVENT WAS NOT CAUSED BY BWI EQUIPMENT AND DECLINED SERVICE AS NO MALFUNCTION OF THE DEVICE WAS NOTED. THE DEVICE HISTORY RECORD FOR STOCKERT GENERATOR SERIAL NUMBER (B)(4) SHOWS THAT NO MANUFACTURING OR TEST FAILS WERE NOTED DURING THE MANUFACTURING CYCLE RELATED TO FUNCTIONALITY OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCTS: COOLFLOW PUMP: MODEL# M-5491-02, SERIAL# (B)(4); EZ STEER THERMOCOOL SF NAV: MODEL# D-1313-04-S, LOT # 15884730L (CUSTOMER DISPOSED OF); CARTO 3: MODEL # M-4800-01, SERIAL# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUFFERED A SECOND DEGREE SKIN BURN, DISCOVERED UNDER THE INDIFFERENT ELECTRODE AFTER AN AFIB ¿ PAROXYSMAL PROCEDURE. A THERMOCOOL SF CATHETER WAS IN USE AT 40 WATTS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407557 STOCKERT 70 RF GENERATOR RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE DRF STOCKERT GMBH M-5463-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R