BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 4130826 · Received September 30, 2014

    Report

    Report Number
    2938836-2014-16258
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    August 12, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE HOSPITAL FOR DEVICE CHANGE OUT DUE TO ERI. PRIOR TO THE REVISION, THE RIGHT VENTRICULAR LEAD EXHIBITED POOR SENSING, AN INCREASE IN PACING LEAD IMPEDANCE, AND AN INCREASE IN CAPTURE THRESHOLD. AN X-RAY REVEALED THAT THE DEVICE HAD MIGRATED IN THE POCKET AND THE LEAD HAD BECOME WRAPPED AROUND THE DEVICE. THE LEAD WAS CAPPED AND REPLACED WITHOUT CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607485 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7120/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention V-193, 490732