BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STOCKERT 70 RF GENERATOR

    MDR report key: 2120761 · Received June 10, 2011

    Report

    Report Number
    9612355-2011-00018
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    April 25, 2011
    Report Date
    May 24, 2011
    Manufacturer
    STOCKERT GMBH
    Product Code
    DRF
    PMA / PMN Number
    P990071
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PER USER FACILITY (MEDWATCH): MANUFACTURER RESPONSE FOR CARTO 3 RMT ELECTRO ANATOMIC MAPPING SYSTEM, EO MED ELECTROPHYSIOLOGY RECODING SYSTEM, X PER HEMODYNAMIC RECORDING SYSTEM, ZOLL M SERIES DEFIBRILLATOR, SIEMENS ARTIS ZEE FLUORO SYSTEM, STEREOTAXIS/ NIOBE REMOTE MAGNETIC NAVIGATION SYSTEM, MEDTRONIC DUAL CHAMBER PACEMAKER (PER SITE REPORTER) MEDTRONIC REP HERE DURING PROCEDURE, CALLED TECHNOLOGY DEPARTMENT. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? SUCCESSFUL SINO ATRIAL NODE MODIFICATION. ELECTROPHYSIOLOGICAL STUDY WITH PROGRAMMED STIMULATION IN THE RIGHT ATRIUM AND THE RIGHT VENTRICLE. CORONARY SINUS RECORDING. THREE- DIMENSIONAL MAPPING OF THE RIGHT ATRIUM WITH CARTO/RMT STEREOTAXIS, USING ELECTROGRAM VOLTAGE AND THREE- DIMENSIONAL MAPPING. CONSCIOUS SEDATION. PERMANENT DUAL- CHAMBER PACEMAKER REPROGRAMMING. ACCORDING TO THE CUSTOMER, THE ISSUE WITH THE PACEMAKER OCCURRED WHEN THE STEREOTAXIS MAGNETS WERE PACED IN THE NAVIGATE POSITION. ACCOUNT ONLY REPORTED THE ISSUE TO BWI BECAUSE CARTO 3 RMT SYSTEM AND STOCKERT 70 RF GENERATOR WERE USED IN CONJUNCTION WITH THE STEREOTAXIS SYSTEM. THE CUSTOMER INDICATED THAT THIS ISSUE IS NOT RELATED TO THE BWI EQUIPMENT AND DECLINED REPAIR/SERVICE. ACCOUNT HAS DETERMINED THAT THE CARTO® 3 RMT SYSTEM AND STOCKERT 70 RF GENERATOR ARE READY FOR USE. IN FUTURE, IF THE ADDITIONAL INFORMATION IS RECEIVED, A 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA. CONCOMITANT DEVICES: CARTO 3 RMT SYSTEM, CATALOG # FG560000, SERIAL # (B)(4). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER WAS CONTACTED AND EXPLAINED THAT THE ISSUE WITH THE PACEMAKER OCCURRED WHEN THE STEREOTAXIS MAGNETS WERE PLACED IN THE NAVIGATE POSITION. ACCOUNT DOES NOT REQUIRE THE STOCKERT TO BE FUNCTIONAL TESTED. 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.

    Description of Event or Problem · 1

    THE PATIENT'S DUAL CHAMBER MEDTRONIC PACEMAKER WAS SET TO DEMAND PACING ONLY MODE (VVI) AT RATE OF 40 BEATS PER MINUTE DURING A PROCEDURE USING STEREOTAXIS MAGNETIC NAVIGATION SYSTEM (MNS). WHEN THE MNS SYSTEM WAS MOVED INTO NAVIGATE POSITION, THE PACEMAKER WENT INTO "MAGNET MODE" (VOO) ASYNCHRONOUS PACING AT 85 BEATS PER MINUTE. TO PREVENT COMPLICATIONS FROM INAPPROPRIATE PACING, THE OUTPUT WAS DECREASED FROM 2.0 V TO 0.5 V (TO INTENTIONALLY LOSE CAPTURE AND PREVENT PACING). DURING FIRST APPLICATION OF RADIO FREQUENCY (RF) ABLATION, ECG MORPHOLOGY CHANGED TO WHAT APPEARED TO BE PACED BEATS AT ABOUT 130 BEATS PER MINUTE AT HIGHER OUTPUT. WHEN RF ABLATION WAS TERMINATED, THE DEVICE WOULD STOP PACING AND THE PATIENT'S UNDERLYING TACHYCARDIA AT 145 BEATS PER MINUTE WAS SEEN ON ECG. THE PHENOMENON WAS REPEATEDLY REPRODUCED WITH RF APPLICATION. GROUNDING PAD LOCATION WAS MOVED FROM LEFT FLANK TO LEFT THIGH, WHICH INTERMITTENTLY RESOLVED THE ISSUE. MEDTRONIC REP ON SITE WAS CONSULTED, AND MEDTRONIC ENGINEER CALLED BY TELEPHONE, BUT NO CLEAR CAUSE WAS IDENTIFIED. MEDTRONIC REP ARRIVED IN ROOM TO PERFORM DEVICE INTERROGATION ONCE THE MNS SYSTEM WAS MOVED TO STOWED POSITION. ERROR MESSAGE ON DEVICE INDICATED IT HAD GONE TO RESET WHICH RETURNED DEVICE TO THE DEFAULT FACTORY SETTINGS OF DDD (DUAL-CHAMBER PACING) 60 - 130, OUTPUT OF 3.5 V. PATIENTS LOW THRESHOLD (APPROXIMATELY 1.0V) ALLOWED MAX TRACKING PACING AT 130 BEATS PER MINUTE TO CAPTURE AND HER UNDERLYING TACHYCARDIA DID NOT REQUIRE PACING WHEN OFF RF. HAD THE PATIENT BEEN PACEMAKER DEPENDENT WITH A THRESHOLD ABOVE 3.5V, NO PACING OR LACK-OF-CAPTURE AND ASYSTOLE WOULD HAVE OCCURRED. CONVERSELY, HAD THE PATIENT HAD HEART FAILURE OR POOR CARDIAC FUNCTION, THE RAPID VENTRICULAR PACING AT 130 BEATS PER MINUTE MAY HAVE CAUSED HEMODYNAMIC COLLAPSE. THEREFORE IT WAS FELT THIS SHOULD BE REPORTED TO MEDSUN/(B)(6) AS A SIGNIFICANT EVENT WITH POTENTIAL TO CAUSE HARM. THE PACEMAKER IS STILL IMPLANTED AND THE PATIENT HAD A GOOD OUTCOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR