BEUDAMED
    FDA Adverse Event Death Summary report: N

    STOCKERT EP-SHUTTLE RADIO FREQUENCY GENERATOR

    MDR report key: 3528443 · Received December 19, 2013

    Report

    Report Number
    9612355-2013-00056
    Event Type
    Death
    Date Received
    December 19, 2013
    Date of Event
    November 22, 2013
    Report Date
    December 13, 2013
    Manufacturer
    STOCKERT GMBH
    Product Code
    DRF
    PMA / PMN Number
    P990071
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS USED DURING THE PROCEDURE: CARTO 3 SYSTEM: MODEL #: FG-5400-00M, SERIAL #: (B)(4). COOL FLOW PUMP: MODEL #: M-5491-02. SERIAL #: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT, TWO WEEKS AFTER A SUCCESSFUL ATRIAL FLUTTER ABLATION PROCEDURE, A PATIENT DIED DUE TO AN ESOPHAGEAL FISTULA. THE PROCEDURE TOOK PLACE ON (B)(6) 2013 AND THE PATIENT DECEASED AT THE HOSPITAL ON (B)(6) 2013. PER THE EVENT DESCRIPTION, THE UNIT WAS SERVICED AND NO ERRORS WERE FOUND. AS PART OF THE SERVICE PERFORMED TO THE UNIT, THE SELECTOR KNOB WAS PROPERLY PLACED AND THE MDV BOARD WAS CALIBRATED, THESE FINDINGS DOES NOT REPRESENT ANY DEVICE FAILURE AND DOES NOT CONTRIBUTE TO THE REPORTED EVENT. FUNCTIONAL AND SAFETY TEST WAS PERFORMED AS WELL AS PM. THE DEVICE HISTORY RECORD FOR STOCKERT GENERATOR SERIAL NUMBER (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. MANAGEMENT IS NOTIFIED OF FAILURE ANALYSIS THROUGH THE MONTHLY TRENDING REPORTS. NO SIGNIFICANT TRENDS HAVE BEEN IDENTIFIED AT THIS TIME; THEREFORE, NO CAPA ACTIVITY IS REQUIRED. CUSTOMER¿S COMPLAINT WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, TWO WEEKS AFTER A SUCCESSFUL ATRIAL FLUTTER ABLATION PROCEDURE, A PATIENT DIED DUE TO AN ESOPHAGEAL FISTULA. THE PROCEDURE TOOK PLACE ON (B)(6) 2013 AND THE PATIENT DECEASED AT THE HOSPITAL ON (B)(6) 2013. UPON REQUEST, ADDITIONAL INFORMATION WAS PROVIDED STATING THAT APPROXIMATELY TWO WEEKS AFTER THE PROCEDURE; THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM COMPLAINING ABOUT INDIGESTION. THE PATIENT UNDERWENT SEVERAL INVESTIGATIVE TESTS. THE PATIENT SUFFERED A CEREBROVASCULAR INCIDENT WHILE AT THE HOSPITAL AND DIED SUBSEQUENTLY A FEW DAYS LATER. THE AUTOPSY REVEALED A POSSIBLE ESOPHAGEAL FISTULA BUT IT WAS NOT POSSIBLE TO FIND ANY CORRESPONDING HOLE IN THE ATRIUM. THE PHYSICIAN ASSESSED THE EVENT AS POSSIBLY PROCEDURE-RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664534 STOCKERT EP-SHUTTLE RADIO FREQUENCY GENERATOR RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE DRF STOCKERT GMBH 39D-76X

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death