BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 1895667 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04469
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 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
    WI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 LOW IMPEDANCE WAS OBSERVED SINCE (B)(6) 2010. DURING CLINIC VISIT THE DEVICE GAVE AN ALERT FOR HIGH VOLTAGE LEAD IMPEDANCE OUT OF RANGE. HV IMPEDANCE ISSUE WAS REPRODUCIBLE WITH ISOMETRICS. THE POCKET WAS OPENED ON (B)(6) 2010 AND A SMALL ABRASION WAS NOTED ON THE PACE/SENSE PORTION OF THE LEAD. THE LEAD WAS REPAIRED WITH MEDICAL ADHESIVE. LEAD TESTED NORMAL AND REMAINS IMPLANTED.

    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 7120/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention (B)(4)