BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SMART S DX 65/15

    MDR report key: 5473788 · Received March 2, 2016

    Report

    Report Number
    1028232-2016-00725
    Event Type
    Injury
    Date Received
    March 2, 2016
    Date of Event
    February 1, 2016
    Report Date
    February 11, 2016
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Adverse Event
    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 DISLODGEMENT. IT WAS REPLACED WITH LINOX SMART S DX 65/15, SN: (B)(4). THE ASSOCIATED ICD WAS EXPLANTED DUE TO EARLY ERI. NO ADVERSE PATIENT SIDE EFFECTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129501 LINOX SMART S DX 65/15 ICD LEAD NVY BIOTRONIK SE & CO. KG 365500

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization