BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX T 65

    MDR report key: 3092019 · Received May 3, 2013

    Report

    Report Number
    1028232-2013-01211
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    March 19, 2013
    Report Date
    April 22, 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 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 AS WELL AS THE DEVICE DATA RETURNED FOR ANALYSIS. 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. DURING THE ANALYSIS OF THE RETURNED DEVICE DATA, THE CLINICAL OBSERVATION WAS CONFIRMED. ARTEFACTS WERE OBSERVED IN THE VENTRICULAR CHANNEL. HOWEVER, NO CONCLUSIONS CONCERNING THE ROOT CAUSE OF THE ARTEFACTS CAN BE DRAWN FROM THE AVAILABLE DATA. IN SUMMARY, THE LEAD WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR LEAD MANUFACTURING. BASED ON THE INFORMATION AVAILABLE THE ROOT CAUSE FOR THE CLINICAL OBSERVATION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN UNKNOWN IMPLANTATION DURATION OVERSENSING WITH ARTIFACTS AND INAPPROPRIATE THERAPY WERE NOTED. BIOTRONIK RECOMMENDED THE REPLACEMENT OF THE LEAD. A NEW LEAD WAS IMPLANTED ON (B)(6) 2013. THE PATIENT GOT AN ICD REPLACEMENT AT THE SAME TIME DUE TO THE BATTERY DEPLETION. THE LEAD WAS NOT RETURNED FOR ANALYSIS AND THE IMPLANT DATE WAS NOT PROVIDED. NO ADDITIONAL ADVERSE PATIENT SIDE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194688 LINOX T 65 ICD LEAD NVY BIOTRONIK SE & CO. KG 351353

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization