BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTISENSE

    MDR report key: 8488227 · Received April 5, 2019

    Report

    Report Number
    2938836-2019-02488
    Event Type
    Injury
    Date Received
    April 5, 2019
    Date of Event
    May 20, 2010
    Report Date
    April 5, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS REPORT IS A FOLLOW-UP FOR MANUFACTURER REPORT NUMBER "2017865-000-2011". NEW INFORMATION AVAILABLE ON MAR 27, 2019 STATES THAT THE LEAD WAS DISLODGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279441 OPTISENSE PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 1699TC/52 2724489

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention