BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/18

    MDR report key: 4163471 · Received October 10, 2014

    Report

    Report Number
    1028232-2014-003588
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    August 16, 2014
    Report Date
    October 1, 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.

    Additional Manufacturer Narrative · 1

    ON 12/15/2014: IT WAS REPORTED THAT ALL THREE LEADS WERE FOUND TO BE FRACTURED DURING THE EXPLANTATION OF THIS SYSTEM. THE DEVICE CODE FOR THE FRACTURE HAS BEEN ADDED TO THE REPORT.

    Description of Event or Problem · 1

    THE PATIENT WAS TRAVELLING AND RECEIVED NUMEROUS INAPPROPRIATE SHOCKS. WENT TO HOSPITAL WHERE DEVICE WAS REPROGRAMMED. WHEN PATIENT RETURNED HOME WITH OFFICE NOTE, DEVICE INTERROGATION IN THE ER REVEALED A MALFUNCTIONING RV LEAD AND GENERATOR NEARING ERI. THE ENTIRE SYSTEM WAS REMOVED AND REPLACED WITH AN UNKNOWN OEM SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640126 LINOX SD 65/18 ICD LEAD NVY BIOTRONIK SE & CO. KG 350054

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization