BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM PASSIVE FIXATION

    MDR report key: 3791193 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10424
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    March 19, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE FOLLOW UP, ELEVATED CAPTURE THRESHOLD AND PACING LEAD IMPEDANCE WERE OBSERVED. THE PATIENT WAS ASYMPTOMATIC. THE SENSE/PACE PORTION OF THE LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268464 RIATA ST OPTIM PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7070/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention