BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STOCKERT 70 RF GENERATOR

    MDR report key: 2926793 · Received January 23, 2013

    Report

    Report Number
    9612355-2013-00004
    Event Type
    Injury
    Date Received
    January 23, 2013
    Date of Event
    December 26, 2012
    Report Date
    January 3, 2013
    Manufacturer
    STOCKERT GMBH
    Product Code
    DRF
    PMA / PMN Number
    P990071
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THERE WAS A PATIENT SKIN BURN DISCOVERED DURING A POST-ABLATION CHECK-UP IN THE LOCATION OF WHERE THE INDIFFERENT ELECTRODE WAS PLACED DURING THE ABLATION. NO ERRORS WERE FOUND DURING UNIT INSPECTION. FUNCTIONAL AND SAFETY TESTS WERE PERFORMED AS WELL AS PM. NIS BOARD UPGRADE WAS PERFORMED FOR THE STOCKERT. THE PURPOSE FOR THE UPGRADE WAS TO ENHANCE THE FUNCTIONALITY OF THE BOARD AND IT NEED TO BE PERFORMED EVEN IF THE UNIT DID NOT PRESENT ANY MALFUNCTION. 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. CUSTOMER COMPLAINT WAS NOT VERIFIED.

    Additional Manufacturer Narrative · 1

    ADD'L DEVICES: CARTO 3 SYSTEM, MODEL #: M-4800-01, SERIAL #: (B)(4); COOL FLOW PUMP, MODEL #: M-5491-02, SERIAL #: (B)(4); C3 EZ STEER THERMOCOOL SF NON-NAV, MODEL #: D-1314-09-S, LOT #: UNKNOWN; C3 NAV VARIABLE LASSO, MODEL #: D-1290-01-S, LOT #: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    DURING THE AFIB PAROXYSMAL PROCEDURE IT WAS REPORTED THAT THERE WAS A PATIENT SKIN BURN DISCOVERED DURING A POST-ABLATION CHECK-UP IN THE LOCATION OF WHERE THE INDIFFERENT ELECTRODE WAS PLACED DURING THE ABLATION. A THERMOCOOL SF CATHETER WAS IN USE AT 40 WATTS WITH A 15 ML/MIN INFUSION RATE. ADDITIONAL INFORMATION PROVIDED WAS STATING THAT THE BURN/BLISTER WAS CLASSIFIED AS 2ND DEGREE BURN. ANTIBIOTIC LOTION WAS PRESCRIBED TO TREAT THE BURN/BLISTER. PATIENT DID NOT REQUIRE FURTHER TREATMENT. THIS EVENT DID NOT RESULT IN THE PERMANENT NON-TRIVIAL IMPAIRMENT OF PATIENT'S BODY FUNCTION OR PERMANENT DAMAGE TO PATIENT'S BODY STRUCTURE. THIS INCIDENT DID NOT NECESSITATE SURGICAL INTERVENTION TO PRECLUDE PERMANENT, NON-TRIVIAL DAMAGE TO A BODY STRUCTURE. THIS PATIENT WAS BROUGHT IN FOR AN AF ABLATION ON (B)(6) 2012. THE SKIN BURN WAS NOT DIAGNOSED UNTIL A FEW DAYS LATER. THE PATIENT WENT FOR A FOLLOW-UP PROCEDURE VISIT WITH THE PHYSICIAN AND POINTED OUT THE SKIN BURN. PATIENT'S CONDITION WAS IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32865 STOCKERT 70 RF GENERATOR RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE DRF STOCKERT GMBH M-5463-01

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention