BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX S 65

    MDR report key: 3173908 · Received June 17, 2013

    Report

    Report Number
    1028232-2013-01655
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    April 20, 2013
    Report Date
    June 4, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD UNDER COMPLAINT WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR LEAD. THE MANUFACTURING PROCESS FOR THIS LEAD WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE ICD WAS FULLY FUNCTIONAL. IN PARTICULAR, THE SENSING FUNCTION PROVED TO BE FAULTLESS DURING ANALYSIS. THE BATTERY DEPLETION WAS ANTICIPATED. THE LEAD WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR LEAD MANUFACTURING. BASED ON THE INFORMATION AVAILABLE FOR ANALYSIS, NO CONCLUSIONS CAN BE DRAWN REGARDING THE ROOT CAUSE OF THE CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION PERIOD OF ABOUT 26 MONTHS, OVERSENSING WITH INAPPROPRIATE SHOCKS WAS REPORTED. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED. THE LEAD WAS CAPPED AND LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274407 LINOX S 65 ICD LEAD NVY BIOTRONIK SE & CO. KG 351333

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization