BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYLOS DR

    MDR report key: 1861255 · Received October 1, 2010

    Report

    Report Number
    1028232-2010-01984
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    May 26, 2010
    Report Date
    September 1, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PACEMAKER UNDERWENT AN ELECTRICAL INCOMING GOODS CONTROL. THE MEASUREMENT OF THE OUTPUT SIGNAL SHOWED THAT THE PACEMAKER DELIVERED PACING IN THE BACK-UP MODE, DESPITE UNSUCCESSFUL INTERROGATION. THE PACEMAKER WAS THEN OPENED AND ANALYZED DESTRUCTIVELY. THE ANALYSIS OF THE ELECTRONIC MODULE IDENTIFIED A DAMAGED INTEGRATED CIRCUIT THAT CONTRIBUTED TO AN INCREASED POWER CONSUMPTION. ASIDE FROM THE INCREASED POWER CONSUMPTION, THE CIRCUIT OF THE PACEMAKER FUNCTIONED, HOWEVER, ACCORDING TO SPECIFICATION. THE PACEMAKER THUS HAD REGISTERED THE INCREASED POWER CONSUMPTION IN THE IMPLANTED STATE AND AUTOMATICALLY DISPLAYED AN ERROR MESSAGE. PACING BY THE PACEMAKER WAS NOT IMPAIRED BY THIS. THE QUALITY AND PRODUCTION DOCUMENTS OF THE PACEMAKER WERE ANALYZED. NO DEVIATIONS FROM THE SPECIFICATIONS COULD BE FOUND DURING PRODUCTION. THE POWER CONSUMPTION DURING FINAL TESTING AT BIOTRONIK WAS AS EXPECTED. IN SUMMARY, THERE WAS AN INCREASED POWER CONSUMPTION DUE TO A DAMAGED INTEGRATED CIRCUIT. THE PACEMAKER DISPLAYED A CORRESPONDING ERROR MESSAGE AS RESPONSE.

    Description of Event or Problem · 1

    AFTER AN IMPLANTATION TIME OF ABOUT 10 MONTHS, IT WAS REPORTED THAT THE PACEMAKER COULD NOT BE INTERROGATED AND WAS EXPLANTED. NO DETERIORATION OF THE PT'S STATE OF HEALTH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYLOS DR PACEMAKER NVZ BIOTRONIK SE & CO. KG 341826

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization