BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/16

    MDR report key: 3232183 · Received July 17, 2013

    Report

    Report Number
    1028232-2013-01948
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    April 23, 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

    THE PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED, INCLUDING A VISUAL AND AN ELECTRICAL ANALYSIS. THE INSPECTION OF THE LEAD DEMONSTRATED A FRACTURED CONDUCTOR CABLE TO THE RV SHOCK COIL, WHICH CAN BE CONSIDERED AS THE ROOT CAUSE FOR THE HIGH SHOCK IMPEDANCE MENTIONED IN THE COMPLAINT DESCRIPTION. BASED ON THE CHARACTERISTICS OF THIS DAMAGE, 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 DAMAGES OCCURRED MOST LIKELY DURING THE EXPLANTATION PROCEDURE. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    OUS MDR - IT WAS REPORTED THAT AFTER AN IMPLANT DURATION OF ABOUT 54 MONTHS THE SHOCK IMPEDANCE WAS OUT OF RANGE (200 OHMS). NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED. THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331087 LINOX SD 65/16 ICD LEAD NVY BIOTRONIK SE & CO. KG 350053

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization