BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REOCOR D

    MDR report key: 3984485 · Received August 6, 2014

    Report

    Report Number
    1028232-2014-002743
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    June 6, 2014
    Report Date
    July 28, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    OVJ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 10/20/2014: WE WERE INFORMED THIS DEVICE HAD BEEN RETURNED FOR ANALYSIS. AFTER THE DEVICE WAS RETURNED IT WAS SUBJECTED TO A VISUAL, MECHANICAL AND FUNCTIONAL TEST. ELECTRICAL FUNCTIONALITY WAS WITHIN SPECIFICATIONS DURING ANALYSIS. THERE WAS NO INDICATION OF A MATERIALS OR MANUFACTURING DEFECT. ATTEMPTS TO REPRODUCE THE COMPLAINT WERE THEN UNDERTAKEN. WITH A STANDARD DDD SETTING OF 60PPM, 200MS AV DELAY, 5V PACING AMPLITUDE, 3MV SENSITIVITY AND A SEPARATE CONNECTION OF THE PACING CHANNELS OVER 500OHM, THERE WAS NO SENSING IN THE VENTRICLE, AS EXPECTED. NEXT, THE VENTRICULAR SENSITIVITY WAS INCREASED TO ITS MAXIMUM (1MV). HERE, AS WELL, THERE WAS NO VENTRICULAR SENSING. THEN THE ATRIAL AMPLITUDE WAS INCREASED TO THE MAXIMUM SETTING OF 17V. AGAIN, NO VENTRICULAR SENSING COULD BE DETERMINED. ONLY AFTER A RESISTANCE OF BELOW 500OHM WAS CONNECTED BETWEEN THE TWO PACING CHANNELS COULD THE COMPLAINT BE REPRODUCED. THIS CONNECTION SCENARIO CORRELATES, E.G., WITH CARDIAC WIRES THAT ARE TOO CLOSE TO EACH OTHER IN THEIR PLACEMENT AND AT THE SAME TIME REOCOR HAS THE MAXIMUM ATRIAL PACING AMPLITUDE SETTING AND A HIGH DEGREE OF VENTRICULAR SENSING. WHILE OBSERVING THE BEHAVIOR IN THE VENTRICLE, THERE WAS BLANKING AT THE TIME OF THE ATRIAL PACING AS PER SPECIFICATIONS. THE REOCOR VENTRICULAR CHANNEL IS NON-RESPONSIVE DURING THE ABOUT 20 MS BLANKING PERIOD. THIS SHORT BLANKING PERIOD PERMITS REOCOR TO SENSE VENTRICULAR SENSE EVENTS WITH SHORT AV DELAYS. IF BOTH PACING CHANNELS ARE LINKED BY A LOW IMPEDANCE (E.G., THE CARDIAC WIRES ARE PLACED TOO CLOSE TO ONE ANOTHER) THERE IS STILL RESIDUAL VOLTAGE IN THE INPUT CIRCUITRY WITH THIS SHORT CROSS-CHANNEL BLANKING OF HIGH ATRIAL STIMULUS. DUE TO THE HIGH VENTRICULAR SENSITIVITY SETTING, THIS RESIDUAL VOLTAGE IS SENSED AS A SENSE AFTER THE BLANKING. THE OFFSET BY THE BLANKING BETWEEN THE PACE (ATRIUM) AND SENSE (VENTRICLE) LED IS SO SHORT THAT IT IS HARDLY DETECTABLE FOR AN OBSERVER. THEREFORE, THERE IS AN EFFECT AS IF THE ATRIUM AND VENTRICLE WOULD BE BLINKING AT THE SAME TIME. IN SUMMARY, THERE IS NO INDICATION OF A MATERIALS OR MANUFACTURING DEFECT. THE CLINICAL COMPLAINT DESCRIBED COULD BE REPRODUCED ONLY UNDER EXTREME CONDITIONS. THE CROSS-TALK OBSERVED CAN BE AVOIDED AT ANY TIME BY EITHER PLACING THE ATRIAL AND VENTRICULAR CARDIAC WIRES FARTHER APART OR BY REDUCING THE ATRIAL PACING AMPLITUDE AND THE VENTRICULAR SENSITIVITY.

    Description of Event or Problem · 1

    OUS MDR - IT WAS REPORTED THAT "THE STIMULATION IN THE VENTRICLES IS INHIBITED WHEN THE VOLTAGE FOR THE ATRIAL STIMULATION IS SET HIGH, EVEN THOUGH NO ELECTRICAL ACTIVITY TAKES PLACE IN THE VENTRICLE. THE DEVICE SHOWS AN OBVIOUSLY WRONG SENSING ON THE VENTRICULAR LEVEL AT THE TIME OF THE ATRIAL STIMULATION. DUE TO THIS INCORRECT SENSING, NO CORRECT STIMULATION (DDD PACING) IS POSSIBLE." NO DETERIORATION OF THE PATIENT'S STATE OF HEALTH WAS REPORTED. THE PRODUCT WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459443 REOCOR D EXTERNAL PACEMAKER OVJ BIOTRONIK SE & CO. KG 365529

    Patients

    Seq Age Sex Outcome Treatment
    1 Other