BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTISENSE LEAD

    MDR report key: 8903860 · Received August 16, 2019

    Report

    Report Number
    2017865-2019-12497
    Event Type
    Injury
    Date Received
    August 16, 2019
    Date of Event
    August 2, 2019
    Report Date
    September 3, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    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.

    Description of Event or Problem · 1

    NEW INFORMATION NOTED THAT IT WAS UNCLEAR IF THERE WAS AN INSULATION DAMAGE. THE PATIENT WAS IN PERMANENT ATRIAL FIBRILLATION SO THE PHYSICIAN ELECTED TO CAP THE ATRIAL LEAD AND EXCHANGE THE DEVICE. CAPTURE THRESHOLDS WERE UNABLE TO BE OBTAINED DUE TO THE ATRIAL FIBRILLATION, BUT SENSING AND IMPEDANCE MEASUREMENT WERE STABLE. PATIENT WAS STABLE POST PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S RIGHT ATRIAL LEAD WAS CAPPED ON (B)(6) 2019 DUE TO AN INSULATION ANOMALY. MORE INFORMATION WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697433 OPTISENSE LEAD PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1999/46 3429940

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention