BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SMART S 75

    MDR report key: 2901641 · Received January 2, 2013

    Report

    Report Number
    1028232-2012-03457
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    July 20, 2012
    Report Date
    December 17, 2012
    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

    Description of Event or Problem · 1

    THE ASSOCIATED RA LEAD WAS EXTRACTED AND REPLACED AND THE RV LEAD WAS REPOSITIONED WITH A TYRX POUCH, WHICH WAS PLACED TO PREVENT TWIDDLER SYNDROME. THIS WAS THE SECOND TIME THIS LEAD HAD BEEN DISLODGED DUE TO TWIDDLERS. ALL AVAILABLE INFO SUGGESTS THIS LEAD REMAINS IMPLANTED. IF ADDITIONAL INFO BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683 LINOX SMART S 75 ICD LEAD NVY BIOTRONIK SE & CO. KG 369819

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization