BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMOS DR-T

    MDR report key: 1890567 · Received October 29, 2010

    Report

    Report Number
    1028232-2010-02266
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    May 19, 2010
    Report Date
    October 1, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    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

    THE DEVICE FIRST UNDERWENT A STATUS INTERROGATION, WHICH CONFIRMED THE BATTERY DEPLETION. THE MEMORY CONTENT OF THE DEVICE WAS EXAMINED. THE DOCUMENTED CHARGE PROCESSES RESULTED FROM THE DETECTION OF INTRINSIC SIGNALS. INTERFERENCE, WHICH WOULD INDICATE ANY EXTERNAL INFLUENCES, WAS NOT VISIBLE. THE DEVICE WAS OPENED AND THE BATTERY PROVED TO BE DISCHARGED. THE CURRENT UPTAKE OF THE ELECTRONIC MODULE WAS EXAMINED AND WAS NORMAL. THE ELECTRONIC MODULE WAS CONNECTED TO AN EXTERNAL VOLTAGE SOURCE AND UNDERWENT AN ELECTRICAL FUNCTION CHECK. THE ANTIBRADYCARDIC OUTPUT SIGNAL WAS CORRECT AND MATCHED THE PROGRAMMED VALUES. A FIBRILLATION SIGNAL WAS FED IN, AND THE MODULE REACTED ACCORDING TO SPECIFICATION WITH A DEFIBRILLATION SHOCK. THE SPECIFIED ENERGY LEVEL WAS REACHED. THE CURRENT UPTAKE OF THE ELECTRONIC MODULE UNDER LOAD REMAINED NORMAL. THE BATTERY WAS RETURNED TO THE MFR FOR A DESTRUCTIVE ANALYSIS. THE X-RAY EXAMINATION DID NOT SHOW ANY ANOMALIES OF THE INTERNAL STRUCTURE. THE BATTERY WAS OPENED. A DAMAGED INNER INSULATION WAS IDENTIFIED DURING THE VISUAL INSPECTION. THIS IMPAIRMENT ALLOWED AN INCREASED INTERNAL SELF-DISCHARGE, WHICH CONTRIBUTED TO THE PREMATURE BATTERY DEPLETION. THIS IS NOT A SYSTEMATIC DEVICE BEHAVIOR. IN SUMMARY, THE ANALYSIS OF THE ICD FOUND PREMATURE BATTERY DEPLETION. THE CLINICAL OBSERVATION RESULTED FROM AN INCREASED SELF-DISCHARGE OF THE BATTERY. THE ELECTRONIC MODULE PROVED TO BE FREE OF DEFECTS.

    Description of Event or Problem · 1

    THIS DEVICE WAS EXPLANTED BECAUSE IT SHOWED BATTERY DEPLETION (ERI). DURING THE FOLLOW-UP IN (B)(6) 2010, THE BATTERY STATE HAD STILL BEEN MOL1. NO DETERIORATION OF THE PT'S STATE OF HEALTH WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization