BEUDAMED
    FDA Adverse Event Summary report: N

    LINOX S 65

    MDR report key: 3050241 · Received April 10, 2013

    Report

    Report Number
    1028232-2013-00920
    Date Received
    April 10, 2013
    Date of Event
    March 2, 2013
    Report Date
    March 27, 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. THE ANALYSIS REVEALED MULTIPLE SIGNS OF ABRASION ALONG THE LEAD BODY. IN THE DISTAL PART OF THE LEAD THE INSULATION WAS FOUND RUBBED THROUGH. THIS CAN BE CONSIDERED AS THE ROOT CAUSE FOR THE OBSERVED NOISE, AS MENTIONED IN THE COMPLAINT DESCRIPTION. BASED ON THE CHARACTERISTICS OF THESE 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. THE DATA RETURNED FOR ANALYSIS WERE ANALYZED. THE INSPECTION REVEALED THE PRESENCE OF NOISE IN THE VENTRICULAR AND THE FAR-FIELD CHANNEL. THIS OBSERVATION IS CONSISTENT WITH THE COMPLAINT DESCRIPTION AND THE OUTCOME OF THE LEAD ANALYSIS. THE ANALYSIS 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 21 MONTHS OVERSENSING WAS REPORTED. NO SHOCKS DELIVERED. NO ADVERSE AFFECTS WERE REPORTED. THE LEAD WAS EXPLANTED. THE IMPLANT AND EXPLANT DATES WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149839 LINOX S 65 ICD LEAD NVY BIOTRONIK SE & CO. KG 351333

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization