BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMOS DR-T

    MDR report key: 1902828 · Received November 12, 2010

    Report

    Report Number
    1028232-2010-02312
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Report Date
    October 12, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P000009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE DEVICE WAS INTERROGATED, REVEALING THE BATTERY STATUS MOL 2. THE DEVICE WAS IMPLANTED FOR APPROXIMATELY 22 MONTHS AND 91 CHARGING CYCLES WERE RECORDED TO THE DEVICE MEMORY. THE HEADER OF THE ICD WAS VISUALLY INSPECTED, REVEALING NO ANOMALIES. THE SET SCREWS COULD BE EASILY SCREWED IN AND OUT, THERE WAS NO FOREIGN MATERIAL INSIDE THE HEADER BORES. THE SET SCREWS SHOWED SCREW MARKS ON THE BOTTOM SIDE INDICATING THAT THEY WERE TIGHTENED DURING THE IMPLANTATION. THERE WAS NO INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM. THE MEMORY CONTENT OF THE DEVICE WAS INSPECTED. DURING THE ANALYSIS OF THE AVAILABLE IEGM'S NOISE WAS CONFIRMED IN THE VENTRICULAR CHANNEL. THEREFORE, A SENSING TEST WAS PERFORMED AND THE DEVICE SENSED THE ATTACHED HEART SIGNALS FREE OF NOISE, PROVING THE SENSING FUNCTION OF THE ICD WAS FULLY FUNCTIONAL. THE ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTI-BRADYCARDIA PACING PULSES PROVED TO BE FLAWLESS IN AMPLITUDE AND FREQUENCY. A FIBRILLATION SIGNAL WAS APPLIED AND THE DEVICE DELIVERED A DEFIBRILLATION SHOCK AS SPECIFIED, DOCUMENTING A CORRECT SENSING AND SHOCK DELIVERY. IN PARTICULAR, THE SPECIFIED ENERGY LEVEL WAS REACHED. THE ANALYSIS OF THE ICD REVEALED NO INDICATION OF A DEVICE MALFUNCTION. IN SUMMARY, THE ICD PROVED TO BE FULLY FUNCTIONAL DURING ANALYSIS. NEITHER THE ANALYSIS OF THE LEAD NOR THE ANALYSIS OF THE ICD DID REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    AFTER AN IMPLANTATION TIME OF ABOUT 2 YEARS, THIS ICD AND LEAD WERE REMOVED DUE TO OVERSENSING. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED. THE EVENT AND EXPLANT DATES WERE NOT MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMOS DR-T ICD MRM BIOTRONIK SE & CO. KG 353220

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization