BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 3854734 · Received June 6, 2014

    Report

    Report Number
    2938836-2014-11621
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 27, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYMPTOMATIC PATIENT PRESENTED TO AN UNSPECIFIED HOSPITAL OR CLINIC WITH CARDIAC TAMPONADE AS A RESULT OF SUSPECTED ACUTE PERFORATION. ELEVATED CAPTURE THRESHOLDS AND DECREASED R-WAVE AMPLITUDE WERE OBSERVED. CHEST X-RAY WAS INCONCLUSIVE. THE PATIENT WAS TRANSFERRED FOR A LEAD EXTRACTION PROCEDURE. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331305 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7122Q/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention