BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST. JUDE MEDICAL MODEL 3085

    MDR report key: 10401530 · Received August 13, 2020

    Report

    Report Number
    9681449-2020-00006
    Event Type
    Injury
    Date Received
    August 13, 2020
    Date of Event
    June 20, 2020
    Report Date
    August 13, 2020
    Manufacturer
    OSYPKA MEDICAL GMBH
    Product Code
    DTE
    PMA / PMN Number
    K020896
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED FOR EVALUATION AND WAS RECEIVED ON 2020-07-20. OSYPKA MEDICAL EVALUATED SJM MODEL 3085 S/N (B)(4) WHICH WAS SUBJECT TO THE COMPLAINT AND FOUNT NO FAULT, I.E. IT IS OPERATING ACCORDING TO ITS SPECIFICATIONS. POSSIBLE ROOT CAUSES HAS BEEN DISCUSSED WITH THE REPORTER VIA E-MAIL AND PHONE. IT HAS BEEN AGREED ON: RETROSPECTIVELY WE ARE NOT ABLE TO DETERMINE WHAT CAUSED VENTRICULAR FIBRILLATION. ONE POSSIBILITY IS THAT THE ATRIAL CHANNEL OF THE PACEMAKER TOOK AN ARTIFACT FOR AN INTRINSIC DEPOLARIZATION AND CONDUCTED IT TO THE VENTRICLE (WHICH WAS NOT ANY MORE REFRACTORY), LEADING TO AND EARLY VENTRICULAR STIMULATION WHICH IN TURN CAUSED VENTRICULAR FIBRILLATION IN THIS PATIENT. ANOTHER POSSIBILITY IS THAT THE MARKER SHOWN BY THE ECG MONITOR WAS NOT TRIGGERED BY A PACEMAKER STIMULUS BUT BY SOMETHING ELSE, FOR INSTANCE, THE ONSET OF (NON-PACEMAKER MEDIATED) VENTRICULAR FIBRILLATION.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION HAVE BEEN RECEIVED FROM THE USER WITHIN SEVERAL E-MAIL COMMUNICATION: THE INCIDENT HAPPENED IN THE CARDIAC ITU AFTER A CARDIAC OPERATION (CABG PROCEDURE FOR CORONARY ARTERY DISEASE). THE EXTERNAL PACEMAKER 3085 IS CONNECTED TO THE PATIENT VIA UNIPOLAR EPICARDIAL PACING WIRES TO ATRIUM AND VENTRICLE. PACER WAS SET TO MODE DDD, BACKUP RATE 50 PPM, ATRIAL OUTPUT 5.0 V, SENSING 0.5 MV, VENTRICULAR OUTPUT 8.0 V, SENSING 2.6 MV. PACER WAS SET IN DEMAND MODE AND STIMULATED APPROX. 10% OF THE TIME. INTRINSIC RATE WAS APPROX. 70 PPM. AFTER 7 HOURS NORMAL OPERATION THE PATIENT WENT INTO VENTRICLE FIBRILLATION. THE ITU NURSE WAS PRESENT AND THE PATIENT WAS DEFIBRILLATED IMMEDIATELY. THE PATIENT'S RHYTHM RETURNED IMMEDIATELY WITH NO ADVERSE EFFECTS. THE PATIENT APPEARS TO HAVE SOME INTERMITTENT ECTOPIC BEATS BEFORE THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865542 ST. JUDE MEDICAL MODEL 3085 EXTERNAL PULSE GENERATOR DTE OSYPKA MEDICAL GMBH 3085

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| O