BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/16

    MDR report key: 2212909 · Received July 12, 2011

    Report

    Report Number
    1028232-2011-01509
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 30, 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 DUE TO NOISE CAUSED BY A POSSIBLE FRACTURE. AT THE SAME TIME, THE ICD WAS REPLACED DUE TO ERI INDICATION. THIS LEAD WAS REPLACED AND WAS RETAINED BY THE HOSPITAL. SHOULD ADDITIONAL INFO REGARDING THIS CASE BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SD 65/16 ICD LEAD LWS BIOTRONIK SE & CO. KG 350053

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization