BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 1954939 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00347
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 23, 2010
    Report Date
    December 16, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. OTHER TEXT : DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    MANDATORY MEDWATCH FORM WAS RECEIVED. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INCREASE IN PACING THRESHOLD AND A LOSS OF CAPTURE WERE OBSERVED. EXIT BLOCK WAS SUSPECTED. THE LEAD WAS EXPLANTED WHEN REPOSITIONING WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7121Q/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention