BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/18

    MDR report key: 2771466 · Received September 28, 2012

    Report

    Report Number
    1028232-2012-02459
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 17, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A FOLLOW UP ON (B)(6) 2012, THE PT HAD 20% BATTERY REMAINING ON THEIR DEVICE, AND TODAY AT FOLLOW UP, THE DEVICE IS NOT AT EOS. ON (B)(6) 2012 - NOISE ON THE RV LEAD CAUSED 299 TOTAL CHARGES SINCE THE LAST FOLLOW UP. THE GENERATOR WAS EXPLANTED ON (B)(6) 2012, AND AN X-RAY REVEALED SUBCLAVIAN CRUSH ON THE RV LEAD. THE RV LEAD WAS CUT AND CAPPED, IT REMAINS IMPLANTED AND IS BEING MONITORED FOR CHATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SD 65/18 ICD LEAD LWS BIOTRONIK SE & CO. KG 350054

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization