BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 3801329 · Received May 8, 2014

    Report

    Report Number
    2938836-2014-10923
    Event Type
    Injury
    Date Received
    May 8, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT RECEIVED MULTIPLE INAPPROPRIATE THERAPIES AND WOKE UP FROM THE SHOCKS CONFUSED. THE LEAD REMAINED IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278821 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7000/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1