BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 60/16

    MDR report key: 2040033 · Received March 25, 2011

    Report

    Report Number
    1028232-2011-00686
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    October 25, 2010
    Report Date
    March 14, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P950023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS LEAD EXHIBITED NOISE WHICH LED TO THE DEVICE SENSING VT AND VF DELIVERING ATP THERAPY. DURING THE PROCEDURE ON (B)(6) 2010, THE "PHYSICIAN WAS ABLE TO REPAIR THE RV EGM NOISE BY ADJUSTING THE SET SCREW, HOWEVER NOISE ON THE SHOCK EGM WAS DISCOVERED AND COULD NOT BE RESOLVED." THIS LEAD WAS EXPLANTED AND REPLACED WITH A COMPETITIVE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SD 60/16 ICD LEAD LWS BIOTRONIK SE & CO. KG 363303

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization