BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 4791726 · Received May 22, 2015

    Report

    Report Number
    2938836-2015-26205
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    April 17, 2015
    Report Date
    April 17, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INCREASED THRESHOLD AND DECREASED SENSING WERE OBSERVED. THE PATIENT COMPLAINED OF DIZZINESS. IT WAS SUSPECTED IT MAY NOT BE RELATED TO THE DEVICE. THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2016.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS STABLE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335466 OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) LDA220Q/65 4534657

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention