BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX S 65

    MDR report key: 3381751 · Received October 2, 2013

    Report

    Report Number
    1028232-2013-02810
    Event Type
    Malfunction
    Date Received
    October 2, 2013
    Date of Event
    September 13, 2013
    Report Date
    September 19, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED, INCLUDING A VISUAL AND AN ELECTRICAL ANALYSIS. THE ANALYSIS OF THE LEAD DEMONSTRATED A RUBBED THROUGH INSULATION IN THE REGION OF THE TRICUSPID VALVE. THIS INSULATION DAMAGE CAN BE CONSIDERED AS THE ROOT CAUSE FOR THE OBSERVED ISSUES AS MENTIONED IN THE COMPLAINT DESCRIPTION. BASED ON THE CHARACTERISTICS OF THIS DAMAGE, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO SEVERE MECHANICAL STRESS IN THE IMPLANTED STATE. DIAGNOSTIC IMAGES CLARIFYING THIS ASSUMPTION WERE NOT AVAILABLE FOR ANALYSIS. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS LEAD WAS EXPLANTED AND REPLACED DUE TO IMPEDANCE FLUCTUATIONS BETWEEN 200 AND 500 OHMS AND INTERMITTENT CAPTURE THRESHOLD MEASUREMENTS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED. THE HOSPITAL HAS RETAINED THE LEAD. ON (B)(6) 201313, THIS LEAD WAS RETURNED WITH OOS DOCUMENTATION THAT INDICATES THERE WAS INSULATION FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496998 LINOX S 65 ICD LEAD NVY BIOTRONIK SE & CO. KG 351333

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization