BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 4790162 · Received May 22, 2015

    Report

    Report Number
    3010215456-2015-00167
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    April 22, 2015
    Report Date
    April 22, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC. (CRM-KISTA)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INAPPROPRIATE SHOCKS WERE DELIVERED TO THE PATIENT AND THE INNER COILS WERE FOUND EXTERNALISED ON X-RAY. IT IS UNKNOWN IF THE RIATA LEAD WAS REMOVED OR CAPPED IN SITU. NO FURTHER INFORMATION IS AVAILABLE REGARDING THE PATIENT¿S CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334045 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC. (CRM-KISTA) 1580/65

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention