BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMAX 300 HF-T

    MDR report key: 1771947 · Received July 22, 2010

    Report

    Report Number
    1028232-2010-01592
    Event Type
    Injury
    Date Received
    July 22, 2010
    Date of Event
    February 18, 2010
    Report Date
    July 13, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ICD FIRST UNDERWENT A STATUS INTERROGATION. THE DEVICE STATUS WAS BOL AND 44 CHARGE PROCESSES HAD BEEN DOCUMENTED. THE MEMORY CONTENT OF THE ICD WAS STUDIED; THE REPORTED DISTURBANCES IN THE VENTRICULAR CHANNEL WERE VISIBLE IN THE AVAILABLE IEGMS. THE SIGNAL SENSING OF THE ICD WAS THEN TESTED AND PROVED TO BE FREE OF NOISE. THE ICD SENSED SUPPLIED SIGNALS FREE OF INTERFERENCE. THE ICD'S ABILITY TO PROVIDE THERAPY WAS TESTED. THE ANTIBRADYCARDIAC OUTPUT SIGNAL WAS NORMAL AND MATCHED THE PROGRAMMED VALUES. A FIBRILLATION SIGNAL WAS FED IN AND THE DEVICES REACTED ACCORDING TO SPECIFICATION WITH A DEFIBRILLATION SHOCK. THE SPECIFIED ENERGY LEVEL WAS REACHED. THE CHARGE TIME WAS UNREMARKABLE. THE CONNECTION SYSTEM OF THE DEFIBRILLATOR WAS EXAMINED MECHANICALLY. THE SCREWS OF THE SHOCK AND PACE OUTPUTS WERE NORMAL. LEADS INSERTED AS A TEST WERE EASILY INSERTED WITHOUT ANY ISSUES. THE DRILL HOLE DIMENSION WERE ALL WITHIN IS-1 AND DF-1 STANDARD. DOT-SHAPED BLUISH TARNISHING COLOR WAS IDENTIFIED ON THE HOUSING SURFACE. THE CAUSE FOR THIS COULD HAVE BEEN A CONTACT BETWEEN A LEAD AND THE ICD HOUSING. THE ANALYSIS OF THE ICD DID NOT SHOW ANY DEVIATIONS FROM THE SPECIFICATION THAT COULD BE RELATED TO THE CLINICAL COMPLAINT. A MATERIAL DEFECT OR MANUFACTURING ERROR DID NOT EXIST.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION TIME OF ONE YEAR, THERE WERE ARTIFACTS DETECTED IN THE RV CHANNEL, BUT THERE WERE NO SHOCK DELIVERIES. THE SYSTEM WAS EXPLANTED AND THERE WAS NO OTHER ADVERSE PATIENT EFFECTS REPORTED. LINOX S 65, (B) (4), MDR 1028232-2010-01592.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMAX 300 HF-T ICD NVZ BIOTRONIK SE & CO. KG 355262

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization