BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYLOS DR

    MDR report key: 3871915 · Received June 13, 2014

    Report

    Report Number
    1028232-2014-01951
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 23, 2014
    Report Date
    June 2, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DXY
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE PACEMAKER WAS VISUALLY INSPECTED REVEALING NO ANOMALIES. IN PARTICULAR THE HEADER OF THE DEVICE WAS ANALYZED. THE SET SCREWS COULD BE EASILY SCREWED IN AND OUT AND THERE WAS NO FOREIGN MATERIAL INSIDE THE HEADER BORES. ALL DIMENSIONS OF THE HEADER BORES WERE WITHIN THE RANGE REQUESTED BY THE IS-1 STANDARD SPECIFICATIONS. ALSO THE SPRING ELEMENTS OF THE PACEMAKER DID NOT SHOW ANY DEVIATIONS. NEXT, THE PACEMAKER WAS INTERROGATED AND THE PACEMAKER¿S MEMORY CONTENT WAS ANALYZED INDICATING NO ANOMALIES. THE BATTERY STATUS AFTER 64 MONTHS IMPLANTATION DURATION WAS FOUND TO BE NORMAL AND AS ANTICIPATED. THE ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTI-BRADYCARDIA PACING PULSES PROVED TO BE FLAWLESS IN AMPLITUDE AND FREQUENCY AS PROGRAMMED. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. AN ADDITIONAL LONG-TERM PACING TEST WAS INITIATED. DURING THE TEST, EACH PACING PULSE WAS RECORDED. THE EVALUATION OF THESE PACING PULSES DOCUMENTED REGULAR DEVICE BEHAVIOR. NO INTERMITTENT OR PERMANENT LOSS OF OUTPUT WAS PRESENT. IN SUMMARY, THE DEVICE IS FULLY FUNCTIONAL. WITH REGARD TO THE ISSUES AS MENTIONED IN THE COMPLAINT DESCRIPTION, THE ANALYSIS DID NOT SHOW ANY DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THE PATIENT COMPLAINED OF FEELING DIZZY. ECG DEMONSTRATED INTERMITTENT VENTRICULAR LOC. PHYSICIAN HAS CONCERNS RELATED TO THE HEADER OF THE PACEMAKER. SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350984 CYLOS DR PACEMAKER DXY BIOTRONIK SE & CO. KG 349799

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization