BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 2242929 · Received September 11, 2011

    Report

    Report Number
    2017865-2011-06471
    Event Type
    Injury
    Date Received
    September 11, 2011
    Date of Event
    July 13, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS NORMAL. NO ANOMALY FOUND.

    Description of Event or Problem · 1

    DURING A FOLLOW-UP, AN INCREASE IN THE CAPTURE THRESHOLD WAS OBSERVED. THE PHYSICIAN OPTED TO MONITOR THE LEAD.

    Description of Event or Problem · 1

    NEW INFORMATION REPORTED THAT THE LEAD WAS EXPLANTED.

    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 7122Q/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention