BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM LEAD

    MDR report key: 11798372 · Received May 10, 2021

    Report

    Report Number
    2017865-2021-17680
    Event Type
    Injury
    Date Received
    May 10, 2021
    Report Date
    August 17, 2021
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS NORMAL. NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER:2017865-2021-17679. IT WAS REPORTED THAT THE PATIENT PRESENTED IN-CLINIC FOR A FOLLOW-UP CHECK. UPON REVIEW, THE ATRIAL AND RIGHT VENTRICLE LEADS BOTH EXHIBITED NOISE. THE ATRIAL AND RIGHT VENTRICLE LEADS WERE BOTH EXPLANTED AND REPLACED. PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693735 RIATA ST OPTIM LEAD DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 7020/60 0002138411

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention TENDRIL ST.| TENDRIL ST