BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STOCKERT RF GENERATOR

    MDR report key: 1131973 · Received August 21, 2008

    Report

    Report Number
    9612355-2008-00015
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 22, 2008
    Manufacturer
    STOCKERT GMBH
    Product Code
    DRF
    PMA / PMN Number
    P990071
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE RF GENERATOR WAS RETURNED TO STOCKERT GMBH FOR EVAL. THE ISSUE COULD NOT BE REPLICATED AND THE GENERATOR WAS OPERATING AS EXPECTED. IT WAS DETERMINED THAT THE CAUSE OF EVENT WAS IMPROPER PLACEMENT OF THE ELECTRODE OF THE FLANK OF THE PT AS WELL AS THE INTERACTION WITH ANOTHER MANUFACTURER'S EP RECORDING SYSTEM (NAVX).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE PROCEDURE, THE NURSE REMOVED THE GROUNDING PAD FROM THE PT'S LEFT FLANK AND NOTED ROW OF BROKEN BLISTERS OVER A SIX-INCH AREA. THE LARGEST WAS QUARTER SIZED. NOTHING HAD CAUSED CONCERN DURING THE CASE. ONCE AWAKE, THE PT COMPLAINED OF PAIN AT SITE. THE STOCKERT GENERATOR SETTING DURING THE PROCEDURE WAS 30-35W. THE HOSPITAL USES A CONMED "SUREFIT" INDIFFERENT ELECTRODE PAD THAT IS FILTERED THROUGH A ST JUDE MEDICAL DEVICE. THE ST JUDE DEVICE IS USED IN CONJUNCTION WITH THE NAVX MAPPING SYSTEM. THE HOSPITAL WILL NOT PROVIDE INFO REGARDING TREATMENT OR MEDICAL INTERVENTION (IF ANY) THAT WAS REQUIRED AS A RESULT OF THIS EVENT. THE PT IS REPORTED TO BE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STOCKERT RF GENERATOR RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE DRF STOCKERT GMBH 39D-76X

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other