BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 1955191 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00383
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 27, 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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED ANALYSIS FOUND THAT THE SENSING COIL WAS FRACTURED CLOSE TO THE CRIMP SLEEVE TO THE CONNECTOR RING AS A RESULT OF FATIGUE. DUE TO INCREASED STRESS AND AN ACCELERATED FATIGUE, OVER TIME THE SENSING COIL FRACTURED. THIS CAUSED THE INTERMITTENT OPEN CIRCUIT. .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH LEAD IMPEDANCE WAS OBSERVED. THE PATIENT RECEIVED INAPPROPRIATE HV THERAPIES AS A RESULT. THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7122/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention