BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX S 65

    MDR report key: 2914051 · Received December 7, 2012

    Report

    Report Number
    1028232-2012-03159
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    May 4, 2011
    Report Date
    November 28, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    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 AS WELL AS ON THE 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. THE HM DATA RETURNED FOR ANALYSIS WERE ANALYSED. THE EPISODE LIST DOCUMENTS A SINGLE EPISODE IN (B)(6) 2007. EXCEPT THE INDUCTION TEST IN (B)(6) 2007, NO FURTHER EPISODES WERE DOCUMENTED IN THE AVAILABLE DATA. IN PARTICULAR, NO IEGMS WERE RETURNED FOR ANALYSIS WHICH COULD CONFIRM THE CLINICAL OBSERVATION. THE INAPPROPRIATE SHOCK DUE TO OVERSENSING COULD NOT BE CONFIRMED. IN SUMMARY, THE LEAD WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR LEAD MANUFACTURING. THERE WAS NO INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANT DURATION OF ABOUT 45 MONTHS OVERSENSING WITH AN INAPPROPRIATE SHOCK WAS REPORTED. THE LEAD WAS EXPLANTED, BUT WAS NOT RETURNED FOR ANALYSIS. NO OTHER ADVERSE PT SIDE EFFECTS HAVE BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization