BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 4970436 · Received August 5, 2015

    Report

    Report Number
    2938836-2015-28381
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    June 18, 2015
    Report Date
    June 23, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS CAPPED DUE TO AN INSULATION ANOMALY. THE PATIENT WAS STABLE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512656 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 1581/65 0002213960

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention