BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMAX 540 DR-T

    MDR report key: 6070317 · Received November 1, 2016

    Report

    Report Number
    1028232-2016-04248
    Event Type
    Injury
    Date Received
    November 1, 2016
    Date of Event
    October 3, 2016
    Report Date
    October 17, 2016
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE ICD WAS INTERROGATED, REVEALING THE BATTERY STATUS MOL2. THE ICD WAS IMPLANTED FOR 72 MONTHS AND 42 CHARGING CYCLES WERE RECORDED TO THE DEVICE MEMORY. THE MEMORY CONTENT OF THE DEVICE WAS ANALYZED. DURING THE ANALYSIS OF THE AVAILABLE IEGMS NOISE WAS OBSERVED IN THE RIGHT VENTRICULAR CHANNEL. THEREFORE A SENSING TEST WAS PERFORMED, AND THE DEVICE SENSED THE ATTACHED HEART SIGNALS FREE OF NOISE, PROVING THE SENSING FUNCTION OF THE ICD TO BE FULLY FUNCTIONAL. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. THE ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTI-BRADYCARDIA PACING PULSES PROVED TO BE NORMAL AND IN AMPLITUDE AND FREQUENCY AS PROGRAMMED. 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. IN CONCLUSION, THE MEMORY CONTENT AS WELL AS THE THERAPEUTIC FUNCTIONALITY OF THE ICD WERE INSPECTED. IN THE AVAILABLE IEGMS THE OCCURRENCE OF NOISE WAS OBSERVED IN THE RIGHT VENTRICULAR CHANNEL. HOWEVER, A THOROUGH ANALYSIS OF THE ICD PROVED THE DEVICE TO BE FULLY FUNCTIONAL. BASED ON THE AVAILABLE INFORMATION THE INTEGRITY OF THE LEAD CANNOT BE ASSURED. BIOTRONIK MONITORS THE POST-MARKET PERFORMANCE OF ITS PRODUCTS CLOSELY IN ORDER TO IDENTIFY ANY TRENDS THAT MAY REVEAL OVER TIME A POTENTIAL MANUFACTURING OR DESIGN ISSUE. THE HISTORIC PERFORMANCE OF THE PRODUCT INVOLVED IN THE CURRENT CASE DOES NOT AT THIS POINT REVEAL ANY SUCH TREND.

    Description of Event or Problem · 1

    THIS DEVICE WAS EXPLANTED AT THE SAME TIME AS THE COMPETITOR'S LEADS DUE TO LOSS OF CAPTURE AND INTERMITTENT OVERSENSING. THE PATIENT BECAME UNSTABLE AND WAS RUSHED TO THE OR FOR PERICARDIAL CARTISIS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720802 LUMAX 540 DR-T ICD MRM BIOTRONIK SE & CO. KG 360346

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R