BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SMART S 65

    MDR report key: 3843174 · Received June 2, 2014

    Report

    Report Number
    1028232-2014-01793
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 19, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY FRAGMENTS OF THE LEAD WERE RETURNED. ALL PARTS OF THE LEAD WERE RETURNED FOR ANALYSIS. THE MORPHOLOGY OF THE AREAS CUT SHOWED THAT THE LEAD WAS LIKELY SEVERED DUE TO THE EXPLANTATION. DURING FRAGMENT ANALYSIS, INSULATION WAS WORN AT 7 CM, 21 CM AND 22 CM DISTAL TO THE IS-1 CONNECTOR PIN. INSULATION WEAR INDICATES EXCESSIVE MECHANICAL STRESS ON THE LEAD. LEAD TORSION IN THE PROXIMAL AREA SUGGESTS THAT THE LEAD HAD BEEN TWISTED DURING THE IMPLANTED STATE DUE TO THE PREVIOUSLY REPORTED COMPLAINTS OF TWIDDLER SYNDROME. THE POSITION AND TYPE OF WEAR SUGGEST A SIMULTANEOUS OCCURRENCE OF GREAT PRESSURE OF THE LEAD ON THE ICD HOUSING AND ALSO THE LEAD RUBBING AGAINST THE ICD HOUSING. THERE IS NO X-RAY IMAGING OR OTHER DIAGNOSTIC IMAGING AVAILABLE THAT WOULD PROVIDE INFORMATION ABOUT THE LOCATIONAL RELATIONSHIP OF THE IMPLANTED SYSTEM IN THE BODY. THERE WAS NO INDICATION OF A MATERIALS DEFECT OR A MANUFACTURING DEFECT.

    Description of Event or Problem · 1

    OUS MDR - THE LEAD SHOWED AN INCREASE IN IMPEDANCE TO 2500 OHMS AND IT WAS FOUND THE PATIENT SUFFERED FROM TWIDDLER'S SYNDROME. A NEW LEAD WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321481 LINOX SMART S 65 ICD LEAD NVY BIOTRONIK SE & CO. KG 369818

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization