BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX S 65

    MDR report key: 4210999 · Received October 29, 2014

    Report

    Report Number
    1028232-2014-003758
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    August 21, 2014
    Report Date
    October 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

    UPON RECEIPT, THE LEAD UNDER COMPLAINT WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE LEAD WAS SCRUTINIZED, INCLUDING A VISUAL AND ELECTRICAL INSPECTION. DURING ANALYSIS SIGNS OF ABRASION WERE FOUND ALONG THE LEAD AND THE INSULATION WAS FOUND RUBBED THROUGH IN THE REGION OF THE TRICUSPID VALVE. THE CONDUCTOR CABLE TO THE RV SHOCK COIL WAS FOUND FRACTURED IN THIS AREA. THE LATTER DAMAGE CAN BE CONSIDERED AS THE ROOT CAUSE OF THE HIGH SHOCK IMPEDANCE MEASUREMENTS MENTIONED IN THE COMPLAINT DESCRIPTION. BASED ON THE CHARACTERISTICS AS WELL AS THE LOCATION OF THE DAMAGE, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO EXCESSIVE MECHANICAL FORCES. DEFORMATION TO THE SHOCK COIL AND CUTTINGS TO THE INSULATION BODY WERE OBSERVED WHICH 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 ABOUT 78 MONTHS AFTER THE IMPLANTATION THE SHOCK IMPEDANCE >150 OHMS WAS DETECTED VIA HOME MONITORING. NO ADVERSE PATIENT SIDE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692408 LINOX S 65 ICD LEAD NVY BIOTRONIK SE & CO. KG 351333

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization