BEUDAMED
    FDA Adverse Event Summary report: N

    CYLOS VR

    MDR report key: 1240787 · Received November 12, 2008

    Report

    Report Number
    1028232-2008-01492
    Date Received
    November 12, 2008
    Date of Event
    August 18, 2008
    Report Date
    October 14, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR - THE MEMORY CONTENTS OF THE PACEMAKER WERE READ AND ANALYZED TOGETHER WITH THE ALREADY SUBMITTED MEMORY CONTENTS. THE CLINICAL COMPLAINT COULD BE CONFIRMED, THE PACEMAKER SHOWED AN INCREASED POWER CONSUMPTION. DUE TO THE INCREASED POWER CONSUMPTION, THE MESSAGE WAS DISPLAYED ON THE PROGRAMMER. THE ELECTRICAL INCOMING GOODS INSPECTION TESTED THE ANTIBRADYCARDIC PACING. THE MEASUREMENT OF THE OUTPUT SIGNAL CONFIRMS THAT PACING WORKED CORRECTLY. AS INDICATED BY THE PROGRAMMER, THE PACEMAKER PACED IN A SAFE MODE, WHICH ENSURED SAFE ANTIBRADYCARDIC STIMULATION. NEXT, THE PACEMAKER WAS SUBJECTED TO A DESTRUCTIVE ANALYSIS. A DAMAGED COMPONENT ON THE ELECTRONIC MODULE WAS IDENTIFIED AS CAUSE FOR THE INCREASED POWER CONSUMPTION. AFTER EXCHANGING THE MEMORY BLOCK, THE CURRENT UPTAKE WAS NORMAL, AND THE ELECTRONIC MODULE FUNCTIONED WITHOUT DEVIATIONS FROM THE SPECIFICATIONS. THE QUALITY AND PRODUCTION DOCUMENTS OF THE PACEMAKER WERE ANALYZED. NO DEVIATIONS FROM THE SPECIFICATIONS COULD BE FOUND DURING PRODUCTION. THE POWER CONSUMPTION WAS AS EXPECTED DURING PRODUCTION AT BIOTRONIK. IN SUMMARY, IT CAN BE SAID THAT THE INCREASED POWER CONSUMPTION WAS DETECTED AND THE ERROR MESSAGE DURING FOLLOW-UP WAS DISPLAYED IN RESPONSE. THE PACEMAKER AUTOMATICALLY SWITCHED TO PACING IN THE SAFE MODE.

    Description of Event or Problem · 1

    OUS MDR. IT WAS REPORTED TO US THAT THE PACEMAKER DISPLAYED THE FOLLOWING ERROR MESSAGE DURING A FOLLOW-UP AFTER AN IMPLANTATION TIME OF ABOUT 12 MONTHS: "PACEMAKER HAS HIGH AVERAGE POWER CONSUMPTION AND IS IN A SAFE MODE, SAFE PACING." IN RESPONSE, THE PACEMAKER WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYLOS VR PACEMAKER NVZ BIOTRONIK GMBH AND CO. 349811

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization