BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART S DX 65/17

    MDR report key: 3232165 · Received July 17, 2013

    Report

    Report Number
    1028232-2013-01941
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    March 17, 2013
    Report Date
    July 8, 2013
    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 WAS FOUND DISSECTED AT ABOUT 22 CM DISTAL TO THE IS-1 CONNECTOR PIN. ONLY THE PROXIMAL FRAGMENT WAS RECEIVED FOR ANALYSIS. IT IS REASONABLE TO ASSUME THAT THE LEAD WAS DISSECTED DURING THE EXPLANTATION PROCEDURE. THE RETURNED FRAGMENT WAS VISUALLY AND ELECTRICALLY ANALYZED. THE INSPECTION OF THE INSULATION CONFIRMED THAT THE LEAD FRAGMENT WAS FREE OF INSULATION BREACHES. THE INNER COIL WAS FOUND SLIGHTLY DEFORMED, MOST LIKELY AS A RESULT OF THE SURGERY. THE DC RESISTANCES OF THE CONDUCTOR FRAGMENT WERE INVESTIGATED AND DID NOT SHOW ANY PECULIARITY. IN SUMMARY, THE ICD WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING. DURING THE ANALYSIS OF THE RETURNED LEAD FRAGMENT, NO DEVIATIONS WERE OBSERVED WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. BASED ON THE INFORMATION AVAILABLE FOR ANALYSIS, NO CONCLUSIONS CAN BE DRAWN REGARDING THE ROOT CAUSE OF THE NOISE. THERE WAS NO INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    OUS MDR - IT WAS REPORTED THAT AFTER AN IMPLANT DURATION OF ABOUT 19 MONTHS AN ARTIFACT AND AN ABORTED SHOCK WERE NOTED VIA HOME-MONITORING. NO ADVERSE PATIENT SIDE EFFECTS WERE REPORTED. ONLY THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331754 LINOX SMART S DX 65/17 ICD LEAD NVY BIOTRONIK SE & CO. KG 365501

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization