BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTISENSE LEAD

    MDR report key: 8197909 · Received December 26, 2018

    Report

    Report Number
    2017865-2018-19559
    Event Type
    Injury
    Date Received
    December 26, 2018
    Date of Event
    December 13, 2018
    Report Date
    March 26, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    NVN
    UDI-DI
    05414734502481
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE ATRIAL LEAD WAS CAPPED AND REPLACED.

    Description of Event or Problem · 1

    DURING A REMOTE FOLLOW-UP, NOISE WAS NOTED ON THE ATRIAL LEAD. THE PATIENT WILL CONTINUE TO BE MONITORED AND WAS STABLE WITH NO CONSEQUENCES. MANUFACTURER REPORT NUMBER: 2017865-2018-19557.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE ATRIAL LEAD WAS REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE WITH NO CONSEQUENCES. MANUFACTURER REPORT NUMBER: 2017865-2018-19557-01.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035316 OPTISENSE LEAD PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC. 1999/52 3340863 05414734502481

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R