BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/18

    MDR report key: 5019388 · Received August 20, 2015

    Report

    Report Number
    1028232-2015-02955
    Event Type
    Malfunction
    Date Received
    August 20, 2015
    Date of Event
    August 11, 2015
    Report Date
    August 11, 2015
    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

    THE REPRESENTATIVE REPORTS THAT THE SHOCK IMPEDANCE HAS BEEN GREATER THAN 150 OHMS FOR A FEW MONTHS. THERE IS NO NOISE PRESENT ON THE FAR-FIELD. THE LEAD REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552625 LINOX SD 65/18 ICD LEAD NVY BIOTRONIK SE & CO. KG 350054

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization