BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTISENSE

    MDR report key: 16686849 · Received April 5, 2023

    Report

    Report Number
    2017865-2023-16836
    Event Type
    Injury
    Date Received
    April 5, 2023
    Date of Event
    January 24, 2023
    Report Date
    May 7, 2024
    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
    MI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RELATED MANUFACTURER REPORT NUMBER: 2017865-2023-16837. IT WAS REPORTED DURING REMOTE FOLLOW UP THAT THE BOTH THE ATRIAL AND RIGHT VENTRICULAR LEADS EXHIBITED OVERSENSING DUE TO NOISE. THIS OVERSENSING RESULTED IN PACING INHIBITION. PROGRAMMING CHANGES WERE RECOMMENDED BUT NOT YET COMPLETED. THE PATIENT WAS STABLE AND ASYMPTOMATIC.

    Description of Event or Problem · 0

    NEW INFORMATION RECEIVED NOTED THAT SUBCLAVIAN CRUSH WAS NOTED ON THE LEADS WHEN UNDER FLUOROSCOPY. THE LEADS WERE CAPPED ON (B)(6) 2024 AND SUCCESSFULLY REPLACED. THE PATIENT WAS STABLE AND ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1853467 OPTISENSE PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1699TC/46 2774091

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Male Required Intervention ASSURITY MRI