BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX S 65

    MDR report key: 2002633 · Received February 8, 2011

    Report

    Report Number
    1028232-2011-00291
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 18, 2010
    Report Date
    February 1, 2011
    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

    THIS LEAD WAS EXPLANTED BECAUSE THE PHYSICIAN FELT THERE WAS AN IMPEDANCE ISSUE WITH THIS LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX S 65 ICD LEAD LWS BIOTRONIK SE & CO KG 351333

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization