BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION

    MDR report key: 3901252 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12668
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    May 7, 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
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WAS RETURNED IN TWO SEGMENTS FOR ANALYSIS. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE PORTIONS OF THE LEAD THAT WERE RETURNED WERE OTHERWISE NORMAL. WITHOUT RETURN OF THE ENTIRE LEAD, A COMPLETE ANALYSIS COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A ROUTINE FOLLOW-UP. A STORED EGM SHOWED NOISE. THE NOISE COULD NOT BE REPRODUCED WITH ISOMETRIC TESTING. NO NOISE WAS SEEN AT A SUBSEQUENT FOLLOW-UP VISIT. MONITORING WILL CONTINUE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES HIGH, OUT OF RANGE PACING LEAD IMPEDANCE. THE LEAD WAS EXPLANTED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT HIGH, OUT OF RANGE HIGH VOLTAGE LEAD IMPEDANCE WAS OBSERVED. THE PATIENT WAS ASYMPTOMATIC. LEAD REVISION IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380799 RIATA ST OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7021/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention 1207-36, (B)(4)