BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX S 65

    MDR report key: 3091996 · Received May 3, 2013

    Report

    Report Number
    1028232-2013-01208
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    January 14, 2013
    Report Date
    April 22, 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 INSPECTION. THE ANALYSIS DEMONSTRATED A RUBBED THROUGH INSULATION AT THE PROXIMAL PART OF THE LEAD. THIS INSULATION DAMAGE CAN BE CONSIDERED AS THE ROOT CAUSE FOR THE OBSERVED OVERSENSING ISSUES 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 AS THE RESULT OF INTERACTION WITH THE ICD CAN. DIAGNOSTIC IMAGES CLARIFYING THIS ASSUMPTION WERE NOT AVAILABLE FOR ANALYSIS. THE DEFORMATION OF THE RV SHOCK COIL OCCURRED MOST LIKELY DURING THE EXPLANTATION PROCEDURE. THE ANALYSIS OF THE LEAD DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANT DURATION OF ABOUT 67 MONTHS OVERSENSING WITH ARTIFACTS WERE REPORTED. NO INAPPROPRIATE SHOCKS WERE DELIVERED. NO ADVERSE PATIENT SIDE EFFECTS WERE REPORTED. THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194598 LINOX S 65 ICD LEAD NVY BIOTRONIK SE & CO. KG 351333

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization