BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX S 65

    MDR report key: 1952641 · Received January 3, 2011

    Report

    Report Number
    1028232-2010-02870
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    September 1, 2010
    Report Date
    December 21, 2010
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR - THE PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED. THE ANALYSIS OF THE LEAD DEMONSTRATED A RUBBED THROUGH INSULATION. THIS INSULATION DAMAGE CAN BE CONSIDERED AS THE ROOT CAUSE FOR THE OBSERVED OVERSENSING ISSUES AS MENTIONED IN THE COMPLAINT DESCRIPTION. THE ANALYSIS DID NOT DEMONSTRATE ANY SIGN OF A MATERIAL OR MFG PROBLEM. BASED ON THE CHARACTERISTICS AS WELL AS THE LOCATION OF THE DAMAGE, IT IS REASONABLE TO ASSUME THAT THE LEADS HAD BEEN SUBJECT TO EXCESSIVE MECHANICAL FORCES AS THE RESULT OF MECHANICAL INTERACTION BETWEEN THE LEAD BODY AND THE ICD CAN. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MFG PROBLEM.

    Description of Event or Problem · 1

    OUS MDR - THIS LEAD WAS EXPLANTED AFTER ABOUT 20 MONTHS, DUE TO OVERSENSING. NO 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