BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STOCKERT 70 RF GENERATOR

    MDR report key: 3160185 · Received June 10, 2013

    Report

    Report Number
    9612355-2013-00029
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 17, 2013
    Manufacturer
    STOCKERT GMBH
    Product Code
    DRF
    PMA / PMN Number
    P990071
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFER TO EVALUATION SUMMARY. (B)(4). IT WAS REPORTED THAT AFTER AN ATRIOVENTRICULAR NODAL ABLATION, WHEN THE GROUNDING PAD WAS REMOVED, A BURN ON THE PATIENT'S RIGHT LATERAL CHEST WALL WAS NOTICED. THE BURN WAS A SECOND TO THIRD DEGREE BURN THAT WAS 0.25% FULL THICKNESS AND APPROXIMATELY 2 MM IN DIAMETER WITH BLISTER THAT WAS CLEAR. SILVADENE WAS ADMINISTERED TO THE PATIENT AND THE PATIENT WAS REPORTED TO BE AT HOME IN STABLE CONDITION. THE SIZE OF THE INDIFFERENT ELECTRODE USED DURING THE CASE WAS 7" BY 4 1/2". DURATION PER ABLATION WAS MINIMUM 110 SECONDS, MAXIMUM 120 SECONDS. THE INDIFFERENT ELECTRODE WAS USED IN THIS CASE WAS (B)(4) LAB WITH SERIAL # (B)(4). AFTER A FOLLOW UP, IT WAS STATED THAT THE CUSTOMER DID NOT BELIEVE THE STOCKERT HAD CAUSE OF THE PATIENT ISSUES. THEY DO NOT REQUEST FSE SUPPORT AT THIS TIME. THEY ALSO ASKED FOR A RECOMMENDATION ON PAD TO USE WITH STOCKERT AND ASKED FOR DOCUMENTATION. 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. THE DEVICE MET ALL REQUIREMENTS PRIOR TO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCT: CELSIUS 4MM MODEL# D-1198-06-S, SERIAL # UNKNOWN, (CUSTOMER DISPOSED OF). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN ATRIOVENTRICULAR NODAL ABLATION, WHEN THE GROUNDING PAD WAS REMOVED, A BURN ON THE PATIENT'S RIGHT LATERAL CHEST WALL WAS NOTICED. THE BURN WAS A SECOND TO THIRD DEGREE BURN THAT WAS 0.25% FULL THICKNESS AND APPROXIMATELY 2 MM IN DIAMETER WITH BLISTER THAT WAS CLEAR. SILVADENE WAS ADMINISTERED TO THE PATIENT AND THE PATIENT WAS REPORTED TO BE AT HOME IN STABLE CONDITION. THE SIZE OF THE INDIFFERENT ELECTRODE USED DURING THE CASE WAS 7" BY 4 1/2". DURATION PER ABLATION WAS MINIMUM 110 SECONDS, MAXIMUM 120 SECONDS. THE INDIFFERENT ELECTRODE WAS USED IN THIS CASE WAS VALLEY LAB WITH SERIAL # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260476 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