BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX S 65

    MDR report key: 4152118 · Received October 8, 2014

    Report

    Report Number
    1028232-2014-003549
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    June 27, 2013
    Report Date
    September 25, 2014
    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 SUBJECTED TO AN EXTENSIVE ANALYSIS. ITS PERFORMANCE WAS SCRUTINISED, INCLUDING A VISUAL AND AN ELECTRICAL INSPECTION. THE ANALYSIS REVEALED ABRADED AREAS ALONG THE LEAD BODY WITH A DAMAGED INSULATION AT THE DISTAL PART OF THE LEAD AS A RESULT OF WEAR. THESE DAMAGES CAN BE CONSIDERED TO BE THE ROOT CAUSE OF THE ARTEFACTS MENTIONED IN THE COMPLAINT DESCRIPTION. BASED ON THE CHARACTERISTICS OF THESE DAMAGES IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO SEVERE MECHANICAL STRESS IN THE IMPLANTED STATE. DIAGNOSTIC IMAGES CLARIFYING THIS ASSUMPTION WERE NOT AVAILABLE FOR ANALYSIS. FURTHER INSPECTION REVEALED EXPLANTATION DAMAGES I.E. THE FIXATION HELIX WAS FOUND BENT AND STRETCHED AND THE RV SHOCK COIL WAS FOUND DEFORMED. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    OUS MDR - OVERSENSING WITH INAPPROPRIATE THERAPY WAS REPORTED. THE IMPLANT AND EXPLANT DATES WERE NOT REPORTED. THE LEAD WAS REPLACED AND RETURNED TO BIOTRONIK. APART FROM THE SHOCKS, NO FURTHER ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630867 LINOX S 65 ICD LEAD NVY BIOTRONIK SE & CO. KG 351333

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization