BEUDAMED
    FDA Adverse Event Death Summary report: N

    LINOX SMART S DX 65/15

    MDR report key: 6173108 · Received December 14, 2016

    Report

    Report Number
    1028232-2016-04994
    Event Type
    Death
    Date Received
    December 14, 2016
    Date of Event
    September 26, 2016
    Report Date
    November 30, 2016
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD UNDER COMPLAINT WAS RECEIVED WITH A SEPARATED DF-1 CONNECTOR. BOTH LEAD FRAGMENTS WERE SUBJECTED TO AN EXTENSIVE ANALYSIS. APART FROM THE SEPARATED DF-1 CONNECTOR, THE INNER COIL WAS FOUND BEND 2.5 CM DISTAL TO THE IS-1 CONNECTOR PIN. IT IS ASSUMED THAT THESE FINDINGS OCCURRED DURING THE EXTRACTION PROCEDURE. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS. IN CONCLUSION, THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM. BIOTRONIK MONITORS THE POST-MARKET PERFORMANCE OF ITS PRODUCTS CLOSELY IN ORDER TO IDENTIFY ANY TRENDS THAT MAY REVEAL OVER TIME A POTENTIAL MANUFACTURING OR DESIGN ISSUE. THE HISTORIC PERFORMANCE OF THE PRODUCT INVOLVED IN THE CURRENT CASE DOES NOT AT THIS POINT REVEAL ANY SUCH TREND.

    Description of Event or Problem · 1

    THE PATIENT EXPIRED ON (B)(6) 2016 DUE TO CONGESTIVE HEART FAILURE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824369 LINOX SMART S DX 65/15 ICD LEAD NVY BIOTRONIK SE & CO. KG 365500

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death