BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 540 HF-T

    MDR report key: 3193460 · Received June 27, 2013

    Report

    Report Number
    1028232-2013-01801
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    March 16, 2013
    Report Date
    June 14, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NIK
    PMA / PMN Number
    P070008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE ICD NOR THE LEAD WAS RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE EXISTING MANUFACTURING DOCUMENTS AND THE RETURNED PROGRAMMER DATA. THE IEGMS OF THE ICD HAVE BEEN CHECKED. NOISE WAS DETECTED IN THE RIGHT VENTRICULAR CHANNEL. THIS INTERFERENCE OCCURRED BETWEEN (B)(6) 2013 AND THE (B)(6) 2013 FOR A TOTAL OF 25 CHARGING PROCESSES, OF WHICH ONE ON (B)(6) 2013 RESULTED IN A SHOCK. BASED ON THE INFORMATION MADE AVAILABLE TO US, A MORE DETAILED CAUSE FOR THE NOISE DETECTION CANNOT BE MADE. THE MANUFACTURING PROCESS OF THE ICD AND THE LEAD WAS CHECKED. THE PRODUCTION DOCUMENTS SHOWED NO ABNORMALITIES THAT COULD BE RELATED TO THE COMPLAINT. ALL MANUFACTURING STEPS WERE PERFORMED CORRECTLY.

    Description of Event or Problem · 1

    OUS MDR - OVERSENSING WITH INAPPROPRIATE SHOCK WAS REPORTED. THE PATIENT HAS BEEN DISCHARGED AGAINST MEDICAL ADVICE AND A FEW DAYS LATER THERE WAS CAUSE FOR REVISION, WHICH WAS DONE AT ANOTHER CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291666 LUMAX 540 HF-T CRT-D NIK BIOTRONIK SE & CO. KG 360347

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization