BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STOCKERT 70 RF GENERATOR

    MDR report key: 3062323 · Received April 16, 2013

    Report

    Report Number
    9612355-2013-00017
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 27, 2013
    Manufacturer
    STOCKERT GMBH
    Product Code
    DRF
    PMA / PMN Number
    P990071
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION STILL IN PROGRESS. A SUPPLEMENTAL REPORT OR DEVICE EVALUATION WILL BE SUBMITTED. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM, MODEL #: M-4800-01, SERIAL #: (B)(4). COOLFLOW PUMP, MODEL #: M-5491-02, SERIAL #:(B)(4). EZ STEER THERMOCOOL SF NAVIGATIONAL CATHETER, MODEL #: D-1313-04-S, LOT #:15807459L. SOUNDSTAR CATHETER, MODEL #:M-5723-05, LOT #:UNKNOWN_M-5723-05. LASSO NAVIGATIONAL VARIABLE ECO CATHETER, MODEL #: D-1343-01-S, LOT #:UNKNOWN_D-1343-01-S. C3 EZ STEER CS WITH AUTO ID, MODEL #:D-1263-06-S, LOT #: UNKNOWN_D-1263-06-S. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER THE ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE PHYSICIAN CALLED THE BWI FIELD REPRESENTATIVE. THE PHYSICIAN STATED THAT AFTER THE PROCEDURE WHILE CHECKING THE PATIENT AT THE RECOVERY AREA, IT WAS NOTICED THAT THE PATIENT HAD A BURN AROUND THE INDIFFERENT ELECTRODE. IT WAS UNKNOWN TO THE BWI FIELD REPRESENTATIVE IF ANY MEDICAL INTERVENTION WAS PERFORMED BUT THE PATIENT WAS STABLE. CLARIFICATION HAS BEEN REQUESTED ON THE EVENT, BUT NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162402 STOCKERT 70 RF GENERATOR RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE DRF STOCKERT GMBH M-5463-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SEE SECTION H10