BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/18

    MDR report key: 3871892 · Received June 13, 2014

    Report

    Report Number
    1028232-2014-01945
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 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
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.

    Description of Event or Problem · 1

    LEAD NOISE MANIFESTED ON LEAD DURING SLOW VT EPISODE. DEVICE DETECTED VF DUE TO NOISE AND ABORTED SHOCK, UPON REDETECTION SHOCK WAS DELIVERED TO PATIENT. (B)(6) 2014 - ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. ALL AVAILABLE INFORMATION SUGGESTS THIS SYSTEM REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350290 LINOX SD 65/18 ICD LEAD NVY BIOTRONIK SE & CO. KG 350054

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other