BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART S 65

    MDR report key: 3891487 · Received June 24, 2014

    Report

    Report Number
    1028232-2014-002113
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 9, 2014
    Report Date
    June 12, 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
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION TIME OF ABOUT 21 MONTHS, IT WAS REPORTED THAT OVERSENSING AND INCREASED IMPEDANCES WERE SEEN AFTER A DEVICE CHANGE. IT WAS FURTHER REPORTED THAT THE LEAD WAS SUBSEQUENTLY EXTRACTED. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369396 LINOX SMART S 65 ICD LEAD NVY BIOTRONIK SE & CO. KG 369818

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization