BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STOCKERT EP-SHUTTLE RADIO FREQUENCY GENERATOR

    MDR report key: 3062147 · Received April 16, 2013

    Report

    Report Number
    9612355-2013-00016
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 22, 2013
    Manufacturer
    STOCKERT GMBH
    Product Code
    DRF
    PMA / PMN Number
    P990071
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY. (B)(4). IT WAS REPORTED DURING AN PAROXYSMAL ATRIAL FIBRILLATION (AFIB) PROCEDURE, AFTER THE UPGRADE TO V1.037, THIS EP-SHUTTLE RF GENERATOR SYSTEM -100W TEMPERATURE IS ALMOST "31-32" DEGREE DURING A THERMOCOOL CATHETER PROCEDURE. THIS IS LOWER THAN NORMAL. THE CUSTOMER WAS ADVISED TO CHANGE TO THE CORRECT CATHETER SELECTION AND CHANGE THE SELECTION FROM "SF" TO "THERMCOOL.¿ ONCE THIS WAS DONE, THE SYSTEM RESTORED TO NORMAL. THE DEVICE HISTORY RECORD (DHR) FOR THE STOCKERT GENERATOR SERIAL NUMBER ST-3470 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION STILL IN PROGRESS. A SUPPLEMENTAL REPORT OR DEVICE EVALUATION WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN PAROXYSMAL ATRIAL FIBRILLATION (AFIB) PROCEDURE, AFTER THE UPGRADE TO V1.037, THIS EP-SHUTTLE RF GENERATOR SYSTEM -100W TEMPERATURE IS ALMOST "31-32" DEGREES DURING A THERMOCOOL CATHETER PROCEDURE. THIS IS LOWER THAN NORMAL. THIS ISSUE IS INDICATIVE OF A REPORTABLE EVENT. UPON REQUEST, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. THE DISPLAYED TEMPERATURE WAS 31-32 DURING ABLATION, BUT IN THE PAST THE TEMPERATURE WAS USUALLY 35-36 DEGREES. THE PHYSICIAN FOUND THE ISSUE DURING THE FIRST ABLATION. THE TEMPERATURE CUT-OFF SETTING WAS 43 DEGREES. THE GENERATOR WAS SET TO TEMPERATURE CONTROL MODE. THERE WAS NO ERROR OR WARNING MESSAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163135 STOCKERT EP-SHUTTLE RADIO FREQUENCY GENERATOR RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE DRF STOCKERT GMBH 39D-76X

    Patients

    Seq Age Sex Outcome Treatment
    1