BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 4130814 · Received September 30, 2014

    Report

    Report Number
    2938836-2014-16204
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    August 26, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE LEAD WAS OTHERWISE NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS CAPPED AND REPLACED DUE TO HIGH CAPTURE THRESHOLD. THE PATIENT WAS IN GOOD CONDITION AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607481 DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7171Q/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention