BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STOCKERT 70 RF GENERATOR

    MDR report key: 2224483 · Received August 26, 2011

    Report

    Report Number
    9612355-2011-00029
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 11, 2011
    Manufacturer
    STOCKERT GMBH
    Product Code
    DRF
    PMA / PMN Number
    P990071
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE STOCKERT GENERATOR SETTINGS WERE 60 DEGREES AT 50W. THERE WERE 24 ABLATIONS: 1 FOR 60SECS, 22 FOR 30SECS, AND ONE FOR 9SECS. TOTAL OF 729 SECS ABLATION TIME. CONCOMITANT PRODUCTS USED DURING THE PROCEDURE: CARTO 3 SYSTEM: MODEL #: M-4800-01, (B)(4). NAVISTAR DS CATHETER (PRODUCT NOT RETURNED FOR INVESTIGATION): MODEL #: D-1201-19-S, LOT #.: UNKNOWN. NAVISTAR DS CATHETER (PRODUCT NOT RETURNED FOR INVESTIGATION): MODEL #: D-1201-20-S, LOT #.: UNKNOWN. THE CUSTOMER WAS CONTACTED BY BIOSENSE WEBSTER FIELD SERVICE ENGINEER. THE HOSPITAL STAFF STATED THAT BWI SYSTEMS AND DEVICES USED DURING THE PROCEDURE WERE WITHOUT FAULT. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY. (B)(4). IT WAS REPORTED THAT FOLLOWING A PROCEDURE, THERE WERE SECOND DEGREE GROUNDING PATCH SKIN BURNS NOTICED BY THE PHYSICIAN THE MORNING FOLLOWING THE PROCEDURE. THE CUSTOMER WAS CONTACTED BY (B)(4). THE CUSTOMER STAFF ADVISED THAT THEY JUST WANTED TO REPORT THE EVENT. THERE WAS NO FAILURE WITH THE GENERATOR. THE CUSTOMER DECLINED SYSTEM SERVICE. THE DEVICE HISTORY REVIEW STOCKERT GENERATOR SERIAL NUMBER (B)(4) SHOWS THAT NO MANUFACTURING OR TEST FAILURE WERE NOTED DURING THE MANUFACTURING CYCLE RELATED TO FUNCTIONALITY OF THE DEVICE. THE DEVICE MET ALL REQUIREMENTS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A RIGHT SIDED ATRIAL FLUTTER PROCEDURE, THERE WERE SECOND DEGREE GROUNDING PATCH SKIN BURNS. THE SKIN BURN WAS DESCRIBED AS "BOIL". THE 2 SMALL SKIN BURNS WERE NOTICED BY THE PHYSICIAN ON THE MORNING FOLLOWING THE PROCEDURE. THE PATIENT WAS REFERRED TO A WOUND CARE SPECIALIST, AND THEY PRESCRIBED SILVADENE OINTMENT FOR TREATMENT. THE GROUND PATCH USED WAS A VALLEY LAB SINGLE PATCH, MODEL NUMBER E7506. THE PATCH WAS PLACED HORIZONTALLY ALONG THE PATIENT'S LOWER BACK, JUST ABOVE THE BUTTOCKS. THE PATIENT WAS RATHER LARGE. ALTHOUGH IT WAS VERIFIED THAT COMPLETE ADHERENCE/ GOOD ADHESION UPON PLACEMENT, THE AREA WAS NOT FLAT. THE SPINE AREA BECAME MOIST DURING THE LONG PROCEDURE AND ALLOWED FOR THE BURN TO OCCUR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention