BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR

    MDR report key: 3781842 · Received April 30, 2014

    Report

    Report Number
    2938836-2014-10028
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    February 6, 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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE LEAD WAS OTHERWISE NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MERLIN.NET TRANSMISSION REVEALED INTERMITTENT VENTRICULAR UNDERSENSING. ALTHOUGH PROGRAMMING CHANGES WERE MADE TO RESOLVE THE UNDERSENSING ISSUE, THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE LEAD DUE TO HISTORICALLY LOW R-WAVES. THE PATIENT WAS FINE AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259106 DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7120Q/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention