BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYLOS 990 DR

    MDR report key: 3021904 · Received March 26, 2013

    Report

    Report Number
    1028232-2013-00835
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    April 19, 2012
    Report Date
    March 15, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DXY
    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

    THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. PARTICULARLY THE FINAL ACCEPTANCE TEST PROVED THE DEVICE FUNCTIONS TO BE FLAWLESS. UPON RECEIPT, THE PACEMAKER WAS VISUALLY INSPECTED. THE INSPECTION REVEALED THAT THE HEADER WAS COMPLETELY BROKEN OFF AND WAS DAMAGED SEVERELY, PARTICULARLY THE ATRIAL TERMINAL WAS NOT EXISTENT. THIS DAMAGE OF THE DEVICE INDICATED STRONG FORCES DURING THE EXPLANTATION PROCEDURE. IT WAS ALSO NOTED THAT IN THE VENTRICULAR LEAD PORT A KIND OF GLUE WAS PRESENT IN A REGION WHERE GENERALLY THE SEALING PLUGS ARE IN CONTACT WITH THE LEAD PORT. THE SPRING ELEMENTS OF THE PACEMAKER DID NOT SHOW ANY DEVIATIONS. A CONNECTION OF A LEAD WAS NOT FEASIBLE AS BOTH THE TERMINALS AS WELL AS THE FEED THROUGH WERE DAMAGED. UPON ELECTRICAL INCOMING INSPECTED THE PACEMAKER WAS SUCCESSFULLY INTERROGATED AND THE PACEMAKER'S MEMORY CONTENT WAS ANALYZED DOCUMENTING A FLAWLESS DEVICE BEHAVIOR. THE BATTERY WAS FOUND TO BE SUFFICIENTLY CHARGED AND THE CURRENT CONSUMPTION WAS AS EXPECTED. IN SUMMARY DURING MECHANICAL ANALYSIS IT WAS NOTICED THAT THE HEADER OF THE PACEMAKER WAS BROKE OFF AND THE HEADER WAS FOUND TO BE SEVERELY DAMAGED. RESIDUES OF GLUE COULD BE OBSERVED WHICH MIGHT HAVE CONTRIBUTED TO THE CLINICAL OBSERVATION. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION PERIOD OF ABOUT 39 MONTHS, IT WAS REPORTED THAT DURING EXPLANTATION THE CONNECTOR OF THE VENTRICULAR LEAD WAS COMPLETELY STUCK INTO THE PORT OF THE DEVICE. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED. THIS IS ALL OF THE AVAILABE INFORMATION AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123323 CYLOS 990 DR PACEMAKER DXY BIOTRONIK SE & CO. KG 359483

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization