BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART S 65

    MDR report key: 2914108 · Received December 7, 2012

    Report

    Report Number
    1028232-2012-03186
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    May 24, 2012
    Report Date
    November 28, 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

    THIS LEAD WAS EXPLANTED AND REPLACED ONE DAY POST IMPLANTED DUE TO HIGH DFTS. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SMART S 65 ICD LEAD LWS BIOTRONIK SE & CO. KG 369818

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization