BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 740 VR-T DX PROMRI

    MDR report key: 3201494 · Received July 2, 2013

    Report

    Report Number
    1028232-2013-01841
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 21, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    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 ENCLOSED DEVICE DATA. THE ADDITIONAL INFORMATION THAT WAS PROVIDED TO US WAS ANALYZED. THE CLINICAL OBSERVATION WAS CONFIRMED, SENSING DISTURBANCES WERE NOTED IN THE RIGHT-VENTRICULAR CHANNEL. THE MORPHOLOGY OF THE SENSING DISTURBANCES INDICATES A DISLODGEMENT OF THE LEAD AS A POSSIBLE CAUSE FOR THE CLINICAL COMPLAINT.

    Description of Event or Problem · 1

    OUS MDR - THE ASSOCIATED LEAD WAS EXPLANTED ON (B)(6) 2013 DUE TO NOISE WHICH LEAD TO INAPPROPRIATE SHOCK. IT IS SUSPECTED THIS LEAD HAD DISLODGED SHORTLY AFTER IMPLANT. THERE ARE NO KNOWN COMPLAINTS FOR THIS DEVICE AND IT REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301693 LUMAX 740 VR-T DX PROMRI ICD LWS BIOTRONIK SE & CO. KG 381463

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization