BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTOS VR/CLS

    MDR report key: 1140253 · Received August 29, 2008

    Report

    Report Number
    1028232-2008-01056
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    April 17, 2008
    Report Date
    July 30, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DXY
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR. THE VISUAL ANALYSIS OF THE PACEMAKER SHOWS SCRATCHES ON THE FRONT AND BACK SIDE OF THE PACEMAKER HOUSING. THE LEAD ATTACHMENT SCREW FOR THE DIFFERENT LEAD CONTACT DID NOT SHOW ANY ANOMALIES IN THE ANALYSIS. THE SCREW COULD BE EASILY EXTENDED AND RETRACTED. THE SPRING ELEMENT ALSO DID NOT SHOW ANY ANOMALIES IN THE ANALYSIS. A BIPOLAR TEST LEAD COULD BE CONTACTED SUCCESSFULLY. THE INCOMING GOOD INSPECTION ESTABLISHED THAT THE PACEMAKER WAS PROGRAMMED TO VVI/CLS MODE WITH 40 PPM. THE PACING AMPLITUDE WAS PROGRAMMED TO 6.0 V AT 0.4 MS. THE PACING AND SENSING POLARITY WAS SET TO UNIPOLAR. THE SENSITIVITY WAS 2.0 MV. THE PACEMAKER UNDERWENT A COMPLETE FUNCTION CHECK, AND NO ANOMALIES COULD BE FOUND. THE PACING AND DETECTION FUNCTIONS OF THE PACEMAKER WERE TESTED. THE PACEMAKER PROVED TO BE WITHIN SPECIFICATIONS. THE RETURNED DOCUMENTS WERE ANALYZED. IT WAS NOTED THAT THE R-WAVE TREND HAD WORSENED OVER TIME. THE MEASURED R WAVES REDUCED OVER TIME TO 6 MV (SEE FIG 1 AND FIG 2). THE EXTERNAL ECGS SHOWED REGULAR UNIPOLAR PACING SPIKES AND ALSO PACING PAUSES OF ABOUT 2 S LENGTH. DURING THE LAST FOLLOW-UP, THE PACING AMPLITUDE WAS PROGRAMMED TO 6.0 V, AND THE SENSITIVITY WAS REDUCED TO 2.0 MV. PACING PAUSES WERE STILL OBSERVED. N SUMMARY, IT CAN BE SAID THAT THE PACEMAKER WAS WITHIN SPECIFICATIONS DURING THE ANALYSIS. NO INDICATIONS OF A MATERIAL DEFECT OR MFG ERROR COULD BE FOUND, WHICH COULD HAVE BEEN RELATED TO THE REPORTED EXIT BLOCK. THE DOCUMENTS INCLUDED IN THE SHIPMENT INDICATE AN INHIBITION OF THE PACEMAKER. THIS ASSUMPTION IS SUPPORTED BY THE WORSENED R-WAVE TREND. FURTHERMORE, INHIBITED PACING COULD BE OBSERVED INTERMITTENTLY EVEN AFTER INCREASING THE AMPLITUDE TO 6.0 V. THERE ARE NO INDICATIONS OF A PACEMAKER DYSFUNCTION.

    Description of Event or Problem · 1

    OUS MDR. AN EXIT BLOCK WAS REPORTED AFTER AN IMPLANTATION TIME OF ABOUT 48 MOS. THE PACEMAKER HAD BEEN IMPLANTED TOGETHER WITH A THIRD-PARTY LEAD. THE ECGS SHOWED PACING PEAKS. IT COULD ALSO BE SEEN IN THE R-WAVE TREND THAT THE MEASURE R WAVE HAD DECREASED FROM INITIALLY 15 MV TO 6 MV. THE PACEMAKER WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTOS VR/CLS PACEMAKER DXY BIOTRONIK GMBH AND CO. 122302

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization