BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX T 65

    MDR report key: 2140741 · Received June 15, 2011

    Report

    Report Number
    1028232-2011-01288
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION TIME OF ABOUT 31 MONTHS, IT WAS REPORTED THAT OVERSENSING HAD BEEN DOCUMENTED VIA HOME MONITORING. THEREFORE, THE DEVICE WAS EXPLANTED. NO WORSENING OF THE PT'S STATE OF HEALTH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX T 65 ICD LEAD LWS BIOTRONIK SE & CO. KG 351353

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization