BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 8723690 · Received June 21, 2019

    Report

    Report Number
    2017865-2019-09756
    Event Type
    Injury
    Date Received
    June 21, 2019
    Report Date
    June 21, 2019
    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
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE PATIENT'S TRANSMISSIONS REVEALED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED EPISODES OF OVERSENSING NOISE. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2019. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517103 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1581/65 0002666636

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention