BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STOCKERT 70 RF GENERATOR

    MDR report key: 2970695 · Received February 20, 2013

    Report

    Report Number
    9612355-2013-00006
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 4, 2013
    Manufacturer
    STOCKERT GMBH
    Product Code
    DRF
    PMA / PMN Number
    P990071
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT ON DEVICE EVALUATION WILL BE SUBMITTED ONCE IT IS COMPLETED. REGARDING THE BIOSENSE WEBSTER SYSTEMS, THE LAB MANAGER WAS CONTACTED BY BWI REPRESENTATIVE. THE HOSPITAL EP LAB STAFF ADVISED THAT THIS ISSUE WAS NOT RELATED TO BWI SYSTEMS. THE CUSTOMER DECLINED SYSTEM SERVICE. CONCOMITANT BWI PRODUCTS USED DURING THE PROCEDURE: CARTO 3 SYSTEM: MODEL #: M-4800-01, SERIAL #: (B)(4). NAVISTAR DS CATHETER (DEVICE WAS DISCARDED BY THE CUSTOMER/ NOT RETURNED FOR INVESTIGATION): MODEL #.: D-1201-19-S, LOT #: UNKNOWN. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT AFTER A RIGHT ATRIAL FLUTTER PROCEDURE, A SKIN BURN UNDERNEATH WHERE THE GROUNDING PAD WAS PLACED WAS NOTED. THE CUSTOMER BELIEVED IT WAS DUE TO THE GROUNDING PAD CONTACT ISSUE. OINTMENT WAS APPLIED TO THE PATIENT ON THE SKIN BURN SITE. THE DEGREE OF SKIN BURN IS UNKNOWN. THE PATIENT WAS REFERRED TO THE WOUND CLINIC FOR FURTHER TREATMENT. THE PATIENT UNDERWENT TREATMENT AND EXPECTED TO MAKE FULL RECOVERY. THE PATIENT RETURN ELECTRODE WAS PLACED ON THE LEFT FLANK. THE BRAND AND TYPE OF THE PATIENT RETURN ELECTRODE USED DURING THE PROCEDURE WAS UNKNOWN. IT IS UNCLEAR IF THE BRAND AND TYPE OF THE PATIENT RETURN ELECTRODE WAS ACCORDING TO BWI'S RECOMMENDATION BRAND/ TYPE. UPON FOLLOW UP BY BWI REPRESENTATIVE, THE CUSTOMER STATED THAT THE EVENT WAS NOT RELATED TO ANY BWI EQUIPMENT. THE CUSTOMER DECLINED THE STOCKERT GENERATOR SERVICE. THE DEVICE HISTORY RECORD FOR STOCKERT GENERATOR SERIAL NUMBER (B)(4) SHOWED THAT NO MANUFACTURING OR TEST FAILURE WAS 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 AFTER A RIGHT ATRIAL FLUTTER PROCEDURE, 15 MINUTES OF THE RF DELIVERY THE PATIENT COMPLAINED OF A LEFT FLANK PAIN WHILE AT THE RECOVERY ROOM. A SKIN BURN UNDERNEATH WHERE THE GROUNDING PAD WAS PLACED WAS NOTED. IT WAS STATED THAT THE CUSTOMER BELIEVED IT WAS DUE TO THE GROUNDING PAD CONTACT ISSUE. OINTMENT WAS APPLIED TO THE PATIENT ON THE SKIN BURN SITE. THE DEGREE OF SKIN BURN IS UNKNOWN AT THIS TIME. THE PATIENT WAS REFERRED TO THE WOUND CLINIC FOR FURTHER TREATMENT. THE PATIENT UNDERWENT TREATMENT AND EXPECTED TO MAKE FULL RECOVERY. THE PATIENT'S PROGNOSIS WAS EXCELLENT. FULL RECOVERY WAS ANTICIPATED. CAUSALITY OF THE ADVERSE EVENT WAS STATED TO BE PROCEDURE RELATED. THE PATIENT RETURN ELECTRODE WAS PLACED ON THE LEFT FLANK. THE BRAND AND TYPE OF THE PATIENT RETURN ELECTRODE USED DURING THE PROCEDURE WAS UNKNOWN. IT IS UNCLEAR IF THE BRAND AND TYPE OF THE PATIENT RETURN ELECTRODE WAS ACCORDING TO BWI'S RECOMMENDATION BRAND/ TYPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74595 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