BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3903775 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12790
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    February 1, 2009
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS. LEAD FRACTURE WAS NOTED. THE SENSE/PACE PORTION OF THE LEAD WAS CAPPED AND REPLACED. DEFIB PORTION REMAINS ACTIVE. LATER, DURING A DEVICE BATTERY CHANGE OUT PROCEDURE, THE LEAD WAS THEN FULLY CAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380024 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention