BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION

    MDR report key: 3791190 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10468
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    March 12, 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
    MD, 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 THE PATIENT RECEIVED AN ALERT FOR HIGH, OUT OF RANGE, PACING LEAD IMPEDANCE. HIGH CAPTURE THRESHOLD WAS ALSO NOTED. NO NOISE WAS SEEN WITH ISOMETRICS OR POCKET MANIPULATION. PATIENT WAS ASYMPTOMATIC. LEAD WAS EXPLANTED AND REPLACED. PATIENT IS FINE. THERE WERE NO ADVERSE EFFECTS FROM THE LEAD EXTRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268463 RIATA ST OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7020/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention