BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 540 DR-T

    MDR report key: 3241119 · Received July 22, 2013

    Report

    Report Number
    1028232-2013-01985
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    April 30, 2013
    Report Date
    July 11, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ICD WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE EXISTING PRODUCTION DOCUMENTS, AS WELL AS THE RETURNED DEVICE DATA. THE MANUFACTURING PROCESS OF THIS ICD WAS REVIEWED. THE PRODUCTION DOCUMENTS SHOWED NO ANOMALIES THAT COULD BE RELATED TO THE COMPLAINT. ALL MANUFACTURING STEPS WERE CARRIED OUT CORRECTLY. THE RETURNED DEVICE DATA OF THE ICD WERE CHECKED, AND THE CLINICAL OBSERVATION WAS CONFIRMED. INTERFERENCE IN THE VENTRICULAR CHANNEL WAS VISIBLE IN THE AVAILABLE IEGMS, WHICH LED TO A TOTAL OF 10 CHARGE PROCESSES AND 5 SHOCK DELIVERIES. IN ADDITION, AN INCREASE IN THE RIGHT-VENTRICULAR PACING IMPEDANCE FROM "470 OHM" ON (B)(6) 2013 TO "1789 OHM" ON (B)(6) 2013 THAT WAS DOCUMENTED. X-RAY IMAGES OR DIAGNOSTIC IMAGES OF ANY OTHER KIND THAT COULD PROVIDE INFORMATION ON THE POSITIONAL RELATIONSHIPS OF THE IMPLANTED SYSTEM IN THE BODY WERE NOT AVAILABLE FOR ANALYSIS. THERE WERE NO INDICATIONS OF MATERIAL DEFECTS OR MANUFACTURING ERRORS.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION TIME OF ABOUT 38 MONTHS, OVERSENSING WITH INAPPROPRIATE SHOCKS WAS REPORTED. NO DETERIORATION OF THE PATIENT'S STATE OF HEALTH WAS REPORTED. ONLY THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340948 LUMAX 540 DR-T ICD MRM BIOTRONIK SE & CO. KG 360346

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization