BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART SD 60/16

    MDR report key: 2251832 · Received August 10, 2011

    Report

    Report Number
    1028232-2011-01820
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 27, 2011
    Report Date
    August 8, 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

    THE LEAD WAS EXPLANTED AND REPLACED 6 WEEKS AFTER IMPLANT DUE TO UNEXPLAINED NOISE WHICH LED TO INAPPROPRIATE SHOCKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SMART SD 60/16 ICD LEAD LWS BIOTRONIK SE & CO, KG 359065

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization