BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART S DX 65/17

    MDR report key: 3952910 · Received July 23, 2014

    Report

    Report Number
    1028232-2014-002498
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 16, 2014
    Report Date
    July 14, 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 ANALYSES. ITS PERFORMANCE WAS SCRUTINIZED, INCLUDING A VISUAL AND AN ELECTRICAL INSPECTION. THE ANALYSIS REVEALED A RUBBED THROUGH INSULATION IN THE DISTAL PART OF THE LEAD. THIS INSULATION DAMAGES CAN BE CONSIDERED AS THE ROOT CAUSE FOR THE OBSERVED NOISE, AS MENTIONED IN THE COMPLAINT DESCRIPTION. 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. DURING FURTHER ANALYSIS THE IS-1 CONNECTOR PIN WAS FOUND DAMAGED, WHICH RESULTED MOST LIKELY FROM THE EXPLANTATION PROCEDURE. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION PERIOD OF ABOUT 24 MONTHS, OVERSENSING WITH AN ABORTED SHOCK WAS REPORTED ON (B)(6) 2014. ALL PARAMETERS AT THAT TIME WERE IN RANGE AND THE PATIENT WAS SENT HOME WITH VF ONLY THERAPY. 10 DAYS LATER THE PACING THRESHOLD INCREASED FROM 0.5 TO 2.4 V AND ON (B)(6) THE PACING IMPEDANCE DROPPED TO 222 OHM. IT WAS DECIDED TO OPEN THE POCKET AND EXPLANT THE LEAD. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430542 LINOX SMART S DX 65/17 ICD LEAD NVY BIOTRONIK SE & CO. KG 365501

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization