BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 1895752 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04619
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 30, 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
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. IT IS BELIEVED THAT THE LEAD MAY HAVE BEEN DISLODGED AS THE STORED EGMS SHOWED A DROP IN VENTRICULAR SENSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED BLUNT TRAUMA TO THE CHEST AREA NEAR THE DEVICE LOCATION. LATER THE PATIENT PRESENTED TO THE EMERGENCY ROOM DUE TO A VIBRATORY ALERT FOR PACING LEAD IMPEDANCE OUT OF RANGE. NOISE WAS NOT REPRODUCIBLE ON THE VENTRICULAR CHANNEL BUT WHEN THE VENTRICULAR AUTOCAPTURE WAS TURNED OFF THE IMPEDANCE MEASUREMENTS RETURNED TO NORMAL. 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 16 YR Required Intervention