BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 340 VR-T

    MDR report key: 2903926 · Received November 29, 2012

    Report

    Report Number
    1028232-2012-03020
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P980023
    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 DEVICE WAS INTERROGATED, REVEALING THE BATTERY STATUS ERI. 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. A FIBRILLATION SIGNAL WAS APPLIED AND THE DEVICE DETECTED THE FIBRILLATION SIGNAL AS SPECIFIED AND STARTED THE CHARGING OF A DEFIBRILLATION SHOCK, HOWEVER THE CHARGING WAS ABORTED, INDICATING A DEPLETED BATTERY. THE ICD WAS OPENED. THE VISUAL INSPECTION OF THE INNER ASSEMBLY SHOWED NO ANOMALIES. THE CURRENT CONSUMPTION OF THE ELECTRONIC MODULE WAS WITHIN SPECIFICATION. THE ELECTRONIC MODULE WAS ATTACHED TO AN EXTERNAL POWER SUPPLY. ONCE AGAIN 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 BATTERY WAS SENT TO THE MANUFACTURER. THE MANUFACTURING RECORDS WERE INSPECTED, DOCUMENTING THAT THE BATTERY PARAMETERS WERE WITHIN SPECIFICATION DURING THE BATTERY MANUFACTURING. NO ANOMALIES WERE DOCUMENTED DURING THE PRODUCTION PROCESS, ASSOCIATED TO THIS BATTERY. THE VISUAL INSPECTION OF THE BATTERY DID NOT REVEAL ANY EXTERNAL SIGNS OF DAMAGE. THE ELECTRICAL MEASUREMENT CONFIRMED THE BATTERY DEPLETION. THE DESTRUCTIVE ANALYSIS OF THE BATTERY YIELDED NO ANOMALIES. THE AMOUNT OF CHARGE TAKEN FROM THE BATTERY WAS VERIFIED. THE BATTERY CONDITION WAS FOUND TO BE ANTICIPATED. THERE WAS NO INDICATION OF A WORKMANSHIP PROBLEM OR A MATERIAL DEFECT.

    Description of Event or Problem · 1

    THIS DEVICE REPORTED EOS ON (B)(6) 2012. THE PT HAS BEEN AT A CASINO THAT DAY. THE DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER ICD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMAX 340 VR-T ICD MRM BIOTRONIK SE & CO. KG 355271

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization