BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STOCKERT RF GENERATOR

    MDR report key: 1140931 · Received August 28, 2008

    Report

    Report Number
    9612355-2008-00016
    Event Type
    Injury
    Date Received
    August 28, 2008
    Date of Event
    July 30, 2008
    Report Date
    July 31, 2008
    Manufacturer
    STOCKERT GMBH
    Product Code
    DRF
    PMA / PMN Number
    P990071
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO OBTAINED FROM THE CUSTOMER INDICATES THAT THE TWO BURN WOUNDS WERE SECOND DEGREE BURNS. NO INFO WAS AVAILABLE REGARDING THE WOUND CARE TREATMENT ADMINISTERED. THE HOSP USED A VALLEY LAB GROUNDING PAD. MODEL #E7506, WHICH WAS PLACED ON THE PTS LEFT LOWER BACK DURING THE PROCEDURE. THE LOT# OF THE GROUND PAD WAS NOT AVAILABLE. 44 RF APPLICATIONS WERE DONE DURING THE PROCEDURE. THE PT HAS BEEN RELEASED FROM THE HOSP. THE BIOSENSE WEBSTER TECHNICAL SERVICES CONTACT THE HOSPITAL'S EP LAB REGARDING THIS EVENT. PER CUSTOMER, A WARMING BLANKET WAS PLACED ON THE PT, AND THE PT WAS SWEATING DURING THE PROCEDURE. THE GROUND PAD WAS CURLED UP AT THE EDGES WHEN THEY REMOVED IT FROM THE PT. CUSTOMER DID NOT FIND ANY FAULT WITH THE SOCKERT GENERATOR OR WITH THE GROUND PAD.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT TWO BURN WOUNDS WERE DISCOVERED POST ABLATION UNDERNEATH THE GROUNDING PAD. PER CUSTOMER, ONE BURN WAS APPROXIMATELY THE SIZE OF A HALF DOLLAR AND THE OTHER THE SIZE OF A SILVER DOLLAR. THE PHYSICIAN ORDERED A WOUND CARE CONSULTATION TO BE DONE FOR THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other CARTO SYSTEM| VALLEY LAB GROUND PAD