BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX S 65

    MDR report key: 4240539 · Received November 10, 2014

    Report

    Report Number
    1028232-2014-004030
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    September 6, 2014
    Report Date
    October 29, 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

    UPON RECEIPT, THE LEAD AND THE ICD UNDER COMPLAINT WERE SUBJECTED TO AN EXTENSIVE ANALYSIS. THE ANALYSIS OF THE LEAD REVEALED A RUBBED THROUGH INSULATION IN THE REGION OF THE TRICUSPID VALVE, WHICH CAN BE CONSIDERED TO BE THE ROOT CAUSE OF THE CLINICAL OBSERVATION. BASED ON THE CHARACTERISTICS OF THESES 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. IN THE AVAILABLE IEGMS THE OCCURRENCE OF NOISE WAS OBSERVED IN THE VENTRICULAR CHANNEL. THIS LED TO EXCESSIVE CHARGING CYCLES WHICH PARTIALLY RESULTED IN SHOCK DELIVERIES,CONFIRMING THE CLINICAL OBSERVATION. THE ACTIVATION OF THE EOS STATUS OF THE DEVICE RESULTED FROM THAT SUCCESSIVE CHARGING. HOWEVER, A THOROUGH ANALYSIS OF THE ICD PROVED THE DEVICE TO BE FULLY FUNCTIONAL. THE ANALYSES DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    OUS MDR - THE PATIENT SUFFERED ICD STORMS ON THE MORNING OF (B)(6) 2014, AND WAS RUSHED TO A LOCAL HOSPITAL. THE PATIENT WAS SHOCKED ABOUT 80 TIMES BEFORE THE LOCAL DOCTOR DISABLED THE ICD THERAPY. THE PATIENT SAID HE WAS FINE BEFORE THE SHOCKS. ON (B)(6) THE PATIENT WAS SENT TO ANOTHER HOSPITAL, WHEN THE ICD WAS NOTED TO BE EOS. THE PROCEDURE OF THE REPLACEMENT WAS DONE ON (B)(6), THE LEAD WAS EXTRACTED AND IT WAS SUSPECTED TO BE BROKEN IN AN AREA NOT IN THE SUBCLAVIAN AREA. THE PHYSICIAN BELIEVES THIS CAUSED THE SENSING PROBLEM WHICH CAUSED THE ICD STORMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724197 LINOX S 65 ICD LEAD NVY BIOTRONIK SE & CO. KG 351333

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization