BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX TD 65/16

    MDR report key: 1243193 · Received November 10, 2008

    Report

    Report Number
    1028232-2008-01323
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    July 21, 2008
    Report Date
    October 8, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS DEMONSTRATED A RUBBED THROUGH INNER INSULATION IN A DISTANCE OF SOME 3.5 CM DISTAL TO THE LIGATURE MARKS. IN THAT SECTION, THE ENTIRE LEAD BODY WAS SQUEEZED AND DEFORMED. ALSO, THE CONNECTOR CABLE TO THE RING ELECTRODE AND THE VCS SHOCK COIL WERE FOUND DAMAGED. THESE DAMAGES ARE SUPPOSED TO AFFECT BOTH THE PACING AS WELL AS SENSING CHARACTERISTICS OF THE LEAD. THE ANALYSIS DID NOT DEMONSTRATE ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM. BASED ON THE CHARACTERISTICS OF THESE DAMAGES, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO ABNORMAL MECHANICAL STRESS AS THE RESULT OF THE SUBCLAVIAN CRUSH SYNDROME.

    Description of Event or Problem · 1

    OUS MDR. AFTER AN IMPLANTATION TIME OF ABOUT 20 MONTHS, INAPPROPRIATE THERAPIES DUE TO THE DETECTION OF NOISE IN THE SENSING CHANNEL HAVE BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization