BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/18

    MDR report key: 1894302 · Received November 4, 2010

    Report

    Report Number
    1028232-2010-02472
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    August 23, 2010
    Report Date
    October 8, 2010
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    LWS
    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 DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ACCOMPANYING THIS PARTICULAR DEVICE. THE MANUFACTURING PROCESS FOR THIS DEVICE 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 DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING.

    Description of Event or Problem · 1

    DURING A POCKET REVISION PROCEDURE, THIS LEAD EXHIBITED OUT OF RANGE IMPEDANCE AND THRESHOLD VALUES. THE REPRESENTATIVE NOTICED THAT AN EVENT RECORD TO THE DEVICE MEMORY ON (B)(6) 2009 DEMONSTRATED CORRECT IMPEDANCE AND THRESHOLD VALUES. THE PHYSICIAN ELECTED TO CAP THIS LEAD AND REPLACED IT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SD 65/18 ICD LEAD LWS BIOTRONIK, INC. 350054

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization