BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX TD 65/16

    MDR report key: 1812826 · Received August 11, 2010

    Report

    Report Number
    1028232-2010-01753
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    June 25, 2010
    Report Date
    July 13, 2010
    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
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PER IMPACT ADVERSE EVENT REPORT, THIS LEAD EXHIBITED LOSS OF CAPTURE AND REMAINS IMPLANTED AS A SHOCK ONLY LEAD. A SETROX S 60, (B)(4), WAS IMPLANTED AND USED TO PACE AND SENSE IN THE RIGHT VENTRICLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX TD 65/16 ICD LEAD LWS BIOTRONIK SE & CO. KG 351337

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization