BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/16

    MDR report key: 3970921 · Received July 31, 2014

    Report

    Report Number
    1028232-2014-002649
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 21, 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

    THIS LEAD WAS EXPLANTED AND REPLACED DUE TO OVERSENSING, FRACTURE, NOISE AND INAPPROPRIATE SHOCKS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EVENTS REPORTED. THE HOSPITAL RETAINED THE DEVICE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447422 LINOX SD 65/16 ICD LEAD NVY BIOTRONIK SE & CO. KG 350053

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization