BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STOCKERT 70 RF GENERATOR

    MDR report key: 2390808 · Received December 28, 2011

    Report

    Report Number
    9612355-2011-00041
    Event Type
    Injury
    Date Received
    December 28, 2011
    Date of Event
    October 19, 2011
    Report Date
    December 14, 2011
    Manufacturer
    STOCKERT GMBH
    Product Code
    DRF
    PMA / PMN Number
    P990071
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON FEBRUARY 1, 2011 BIOSENSE WEBSTER INC. (BWI) RECEIVED THE FDA FOLLOW-UP REQUEST, DATED JANUARY 05, 2011 REGARDING REPORT # 9612355-2011-00041 MANUFACTURER REF # (B)(4) REQUESTING MORE INFORMATION ABOUT INVESTIGATION. INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT IN RESPONSE TO THE FDA LETTER WILL BE SUBMITTED ONCE IT IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCTS: CARTO 3 RMT: MANUFACTURE # (B)(4), SERIAL # (B)(4), NAVISTAR: MANUFACTURE # UNKNOWN, LOT # UNKNOWN (DISPOSED). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). NO ERRORS WERE FOUND DURING THE SERVICE, HOWEVER, DURING THE PHYSICAL EVALUATION IT WAS FOUND THAT THE UNIT HAD THE HANDLE, FOOT PEDAL, INDIFFERENT SOCKET AND CATHETER MOD DEFECTIVE, AND THE ISSUE WAS RESOLVED BY REPLACING THEM. THE REPORTED ISSUE COULD NOT BE CAUSED BY THESE DEFECTIVE PARTS. FUNCTIONAL AND SAFETY TEST WAS PERFORMED AS WELL AS THE PREVENTIVE MAINTENANCE AND THE UNIT WAS FOUND FUNCTIONAL. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A GROUNDING PAD 3RD DEGREE BURNS WHILE USING THE STOCKERT GENERATOR WITH ESI VELOCITY MAPPING SYSTEM. THE GROUNDING PAD WAS ADULT SIZE VALLEY LAB MODEL E7506 AND PLACED ON RIGHT LATERAL THIGH. THE SKIN SITE WAS DOCUMENTED AS INTACT AFTER REMOVAL. THE REFERENCED CASE WAS A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) IMPLANT AND ATRIOVENTRICULAR JUNCTION (AVJ) ABLATION WITH CARTO MAPPING. UPON FOLLOW-UP VISIT THE BURN WAS NOTICED AND THERE WAS NO TREATMENT KNOWN.

    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 Other