BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR

    MDR report key: 3791135 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10537
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    March 3, 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
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN DFTS WERE PERFORMED POST IMPLANT, THE EGM REVEALED NOISE. IT WAS SUSPECTED THAT THE CAUSE MAY HAVE BEEN THE CLOSE PROXIMITY OF THE SHOCK COIL TO A PREVIOUSLY CAPPED LEAD. THE ISSUE WAS RESOLVED BY REPOSITIONING THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268858 DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7122Q/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention