BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 4153720 · Received October 8, 2014

    Report

    Report Number
    2938836-2014-16429
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 1, 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 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 LOSS OF VENTRICULAR SENSING DUE TO DISLODGEMENT WAS OBSERVED. THE LEAD WAS EXPLANTED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631845 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7122/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention