BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STOCKERT 70 RF GENERATOR

    MDR report key: 3024196 · Received March 27, 2013

    Report

    Report Number
    9612355-2013-00012
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 28, 2013
    Manufacturer
    STOCKERT GMBH
    Product Code
    DRF
    PMA / PMN Number
    P990071
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION STILL IN PROGRESS. A SUPPLEMENTAL REPORT OR DEVICE EVALUATION WILL BE SUBMITTED. CARTO 3 SYSTEM: MODEL #: M-4800-01, SERIAL #: (B)(4). NAVISTAR: MODEL #: UNKNOWN, LOT #: UNKNOWN. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY. (B)(4). IT WAS REPORTED DURING AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) PROCEDURE, THE ABLATION WOULD RESET ON THE CARTO 3 SYSTEM SCREEN AND THE RECORDING SYSTEM INTERMITTENTLY DURING THE CASE. ALSO, THE TIP OF THE MAPPING CATHETER WOULD TURN GREEN. DURING THIS TIME, THE STOCKERT 70 SYSTEM WOULD CONTINUE ABLATING. IT WAS ADVISED TO REPLACE SOME OF THE CABLES IN ORDER TO SEE IF THE ISSUE WOULD RESOLVE. AFTER A FOLLOW UP, IT WAS STATED THAT THERE WERE NO STOCKERT 70 SYSTEM ISSUES DURING THE FOLLOWING CASE AND THE GENERATOR PERFORMED NORMALLY. THE BWI FIELD REPRESENTATIVE INDICATED THAT THE CUSTOMER DOES NOT REQUIRE A LOANER OR STOCKERT SERVICE AT THIS TIME. THE DEVICE HISTORY RECORD (DHR) FOR THE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) PROCEDURE, THE ABLATION WOULD RESET ON THE CARTO 3 SYSTEM SCREEN AND THE RECORDING SYSTEM INTERMITTENTLY DURING THE CASE. ALSO, THE TIP OF THE MAPPING CATHETER WOULD TURN GREEN. DURING THIS TIME, THE STOCKERT 70 SYSTEM WOULD CONTINUE ABLATING. UPON REQUEST, ADDITIONAL INFORMATION ON THE EVENT WAS REQUESTED FROM THE BWI FIELD REPRESENTATIVE. THE CARTO 3 SYSTEM WAS RESETTING TO 0 AS IF THE ABLATION WAS COMPLETED EVEN THOUGH THE STOCKERT 70 SYSTEM WOULD CONTINUE ABLATING. THE PROCEDURE WAS ABLE TO BE CONTINUED AS THE PROBLEM WAS INTERMITTENT. IT WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES AND THERE WAS NO PATIENT CONSEQUENCE. A 4MM NAVISTAR CATHETER UNDER TEMPERATURE CONTROL WAS IN USE. APPROXIMATELY 10-15 WATTS WAS BEING DELIVERED. THE NORMAL TEMPERATURE INCREASES AND IMPEDANCE DROPS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126249 STOCKERT 70 RF GENERATOR RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE DRF STOCKERT GMBH M-5463-01

    Patients

    Seq Age Sex Outcome Treatment
    1