BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART S 60

    MDR report key: 4841356 · Received June 12, 2015

    Report

    Report Number
    1028232-2015-02001
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    June 4, 2015
    Report Date
    June 4, 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

    NOISE WAS RECORDED ON THE RV CHANNEL LEADING TO INAPPROPRIATE DETECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384586 LINOX SMART S 60 ICD LEAD NVY BIOTRONIK SE & CO. KG 375012

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization