BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 340 DR-T

    MDR report key: 3120368 · Received May 20, 2013

    Report

    Report Number
    1028232-2013-01474
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    June 18, 2012
    Report Date
    May 1, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P000009
    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 VISUALLY INSPECTED. THE VISUAL INSPECTION REVEALED TRACES OF LEAD ABRASION AS WELL AS A SPOT OF MOLTEN TITANIUM ON THE ICD HOUSING. THIS INDICATES AN ARC OVER FROM THE HIGH VOLTAGE CONDUCTOR. THE DEVICE INTERROGATION REVEALED THE BATTERY STATUS EOS. A NUMBER OF 477 CHARGING CYCLES WAS DOCUMENTED. THE MEMORY CONTENT OF THE DEVICE WAS INSPECTED. THE ANALYSIS OF THE SHOCK HOLTER SHOWED THAT AN AMOUNT OF MORE THAN 477 CHARGING CYCLES WAS PERFORMED BY THE DEVICE WITHIN 10 DAYS. THE EOS STATUS OF THE DEVICE RESULTED FROM THAT EXCESSIVE CHARGING. THE AVAILABLE IEGM'S SHOWED THAT THIS CHARGING WAS CAUSED DUE TO THE DETECTION OF NOISE IN THE VENTRICULAR AS WELL AS IN THE FAR-FIELD CHANNEL. THE DEVICE WAS SUBJECTED TO AN ELECTRICAL ANALYSIS. THE EOS STATUS WAS REMOVED WITH A TECHNICAL PROGRAMMER AND SUBSEQUENT INTERROGATION SHOWED 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, HOWEVER THE ABILITY OF THE DEVICE TO DELIVER DEFIBRILLATION SHOCKS WAS FOUND COMPROMISED AS THE BATTERY WAS FOUND TO BE ALMOST DEPLETED. THE ICD WAS IMPLANTED FOR 31 MONTHS; 477 CHARGING CYCLES WERE DOCUMENTED IN THE ICD'S MEMORY. THE AMOUNT OF CHARGE TAKEN FROM THE BATTERY WAS VERIFIED. THE BATTERY CONDITION WAS FOUND TO BE ANTICIPATED. IN SUMMARY, THERE WAS NO INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM. THE ERI BATTERY STATUS WAS ANTICIPATED.

    Description of Event or Problem · 1

    THIS DEVICE IS AT EOS INDICATION AND WAS REPLACED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222045 LUMAX 340 DR-T ICD MRM BIOTRONIK SE & CO. KG 355267

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization