BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMAX 540 VR-T DX

    MDR report key: 3232147 · Received July 17, 2013

    Report

    Report Number
    1028232-2013-01942
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    March 17, 2013
    Report Date
    July 8, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS OF THE RECEIVED X-RAY IMAGES REVEALED THAT THE ICD ROTATED ABOUT 170 DEGREES DURING THE WEEK AFTER IMPLANT OF THE SYSTEM. THE ICD AND THE LEAD WERE REPOSITIONED ON (B)(6) 2011. THE ICD WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE AS WELL AS ON THE RETURNED DEVICE DATA. THE MANUFACTURING PROCESS FOR THE LEAD AS WELL AS FOR THE 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 CLINICAL OBSERVATION. THE RETURNED ICD DATA HAVE BEEN ANALYSED. DURING THE ANALYSIS OF THE AVAILABLE IEGM'S NOISE WAS OBSERVED IN THE FF AND THE VENTRICULAR CHANNEL, THEREBY CONFIRMING THE CLINICAL OBSERVATION. HOWEVER, THERE WAS NO INDICATION OF AN ICD MALFUNCTION. IN SUMMARY, THE ICD WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING. DURING THE ANALYSIS OF THE RETURNED LEAD FRAGMENT, NO DEVIATIONS WERE OBSERVED WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. BASED ON THE INFORMATION AVAILABLE FOR ANALYSIS, NO CONCLUSIONS CAN BE DRAWN REGARDING THE ROOT CAUSE OF THE NOISE. THERE WAS NO INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    OUS MDR - IT WAS REPORTED THAT AFTER AN IMPLANT DURATION OF ABOUT 19 MONTHS AN ARTIFACT AND AN ABORTED SHOCK WERE NOTED VIA HOME-MONITORING. THE LEAD WAS EXPLANTED, BUT ALL AVAILABLE INFORMATION SUGGESTS THIS DEVICE REMAINS ACTIVELY IMPLANTED. NO ADVERSE PATIENT SIDE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331531 LUMAX 540 VR-T DX ICD MRM BIOTRONIK SE & CO. KG 368852

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization