BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 5677295 · Received May 24, 2016

    Report

    Report Number
    3010215456-2016-03332
    Event Type
    Injury
    Date Received
    May 24, 2016
    Date of Event
    April 21, 2016
    Report Date
    April 23, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC. (CRM-KISTA)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE OF THE RIGHT ATRIAL LEAD, THE PATIENT EXPERIENCED ARRHYTHMIA. THE PATIENT WAS TREATED WITH 1/2 FL BOLUS MEDICATION AND THE DEVICE WAS REPROGRAMMED. THE PATIENT WAS DISCHARGED IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331017 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC. (CRM-KISTA) 2088TC/52 P000024346

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention