BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 540 DR-T

    MDR report key: 2914112 · Received December 7, 2012

    Report

    Report Number
    1028232-2012-03165
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    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 ICD WAS VISUALLY INSPECTED. THE VISUAL INSPECTION REVEALED SPOTS OF MOLTEN TITANIUM ON THE ICD HOUSING. THIS INDICATES AN ARC-OVER FROM A HIGH VOLTAGE LEAD CONDUCTOR DURING A SHOCK DELIVERY, REPRESENTING AN EXTERNAL SHORT CIRCUIT. THE ICD WAS SUBJECTED TO AN ELECTRICAL ANALYSIS. THEREBY THE CLINICAL OBSERVATION WAS CONFIRMED, THE DEVICE WAS NOT ABLE TO BE INTERROGATED. THE ICD WAS OPENED AND THE INNER ASSEMBLY WAS INSPECTED. DURING THE INSPECTION OF THE ELECTRICAL MODULE, THE ANALYSIS REVEALED THAT THE OUTPUT STAGES OF THE HIGH VOLTAGE CIRCUIT HAD BEEN DAMAGED. THIS DAMAGE INDICATES A SHOCK DELIVERY INTO AN EXTERNAL SHORT CIRCUIT. DUE TO THE DAMAGE OF THE ELECTRICAL MODULE, THE ICD COULD NOT BE INTERROGATED PROPERLY. THE MANUFACTURING PROCESS FOR THIS ICD WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS WHICH MIGHT BE RELATED TO THE OBSERVED DAMAGE SYMPTOMS. PARTICULARLY THE FINAL ACCEPTANCE TEST PROVED THE ICD FUNCTIONS TO BE FLAWLESS.

    Description of Event or Problem · 1

    ON "(B)(4) 152" - WE WERE INFORMED THIS SYSTEM WAS EXPLANTED DUE TO TWIDDLER'S SYNDROME.

    Description of Event or Problem · 1

    UNABLE TO INTERROGATE DEVICE AND PUGH INDICATOR DOES NOT LIGHT UP WHILE OVER DEVICE AND ALL ATTEMPTS TO TROUBLESHOOT WERE UNSUCCESSFUL. DEVICE TRANSMITTED EARLIER ON SAME DAY OF FOLLOW UP AND 5 DAYS AGO PT STARTED HAVING NOISE ON THE RV LEAD AND FF CHANNEL WITH VF DETECTIONS BUT NO CHARGES WERE INDICATED. SUSPECT LEAD INSULATION BREACH WITH SHOCK SHORTED DEVICE. RECOMMENDED EXPLANTS AND EXPECT POSSIBLE REVISION OF RV LEAD. ON (B)(6) 2012 - THE LEAD AND THE ICED WERE EXPLANTED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMAX 540 DR-T ICD MRM BIOTRONIK SE & CO. KG 360346

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization