BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STOCKERT 70 RF GENERATOR

    MDR report key: 2200189 · Received August 10, 2011

    Report

    Report Number
    9612355-2011-00024
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 12, 2011
    Manufacturer
    STOCKERT GMBH
    Product Code
    DRF
    PMA / PMN Number
    P990071
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FIELD SERVICE ENGINEER SPOKE TO CUSTOMER AND THEY STATED THAT THE ISSUE WAS NOT STOCKERT GENERATOR RELATED. THEY MOVED THE STOCKERT GENERATOR TO A NEW LAB ON THE SAME DAY AND IT PERFORMED NORMALLY. IT WAS MOST LIKELY A PATCH PLACEMENT WORK FLOW ISSUE. CUSTOMER DECLINED REPAIR. THE DEVICE HISTORY RECORD FOR STOCKERT GENERATOR (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. THE CUSTOMER IS CURRENTLY USING THIS DEVICE WITHOUT ANY ISSUES.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: EZ STEER; THERMOCOOL BI-DIRECTIONAL CATHETER, CATALOG # BDI75TCFJRT, LOT # UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IN AN AFIB ABLATION PROCEDURE, IT WAS REPORTED THAT THERE WERE HIGH IMPEDANCE READINGS ON THE STOCKERT WHILE IN USE WITH ESI MAPPING SYSTEM (NON-BWI PRODUCT) AND A VALLEY LAB PATCH. THE IMPEDANCE READING WAS REPORTED AT 230 OHMS. THERE WAS A BURN TO THE PATIENT'S LOWER LEFT FLANK BETWEEN THE BUTTOCKS AND THE MID BACK APPROXIMATELY THE SIZE OF A SILVER DOLLAR. THE PATIENT IS GOING TO A WOUND CARE CENTER TODAY FOR TREATMENT TO THE BURN. THERE WERE NO ERROR MESSAGES TO INDICATE THAT THERE WAS ANY SYSTEM MALFUNCTION. THE INDIFFERENT ELECTRODE CABLE AND PATCH WERE MOVED FROM THE BELLY TO THE LOWER LEG TO TRY TO REDUCE THE IMPEDANCE BUT THIS WAS UNSUCCESSFUL. THE CATHETER WAS CHANGED OUT AND THIS ALSO DID NOT RESOLVE THE IMPEDANCE ISSUE.

    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