BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, SJ4 CONNECTOR

    MDR report key: 1830523 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03430
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    July 30, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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

    A DISTRIBUTOR (B)(4) FORWARDED INFO TO THE MANUFACTURER IN REGARD TO A REPORTED ADVERSE EVENT INVOLVING A TRILOGY 100 VENTILATOR. ACCORDING TO THE DISTRIBUTOR, A (B)(6) INFANT WHO HAD BEEN RECEIVING CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) THERAPY VIA THE TRILOGY 100 VENTILATOR EXPIRED ON (B)(6) 2010. THE CAUSE OF THE DEATH HAS YET TO BE DETERMINED. THERE DOES NOT APPEAR TO BE AN ALLEGATION THE TRILOGY 100 MALFUNCTIONED DURING THE REPORTED EVENT. A GETEMED INFANT APNEA MONITOR WAS ALSO REPORTED TO BE IN USE AT THE TIME OF THE EVENT. THE DEVICES ARE CORRECTLY IN THE POSSESSION OF THE AUTHORITIES AND A FOLLOW-UP REPORT WILL BE FILED WHEN ADDITIONAL INFO IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR LEAD IMPEDANCE HAD INCREASED. AT A SUBSEQUENT FOLLOW-UP, ANOTHER HIGH IMPEDANCE MEASUREMENT WAS OBSERVED. X-RAY DID NOT REVEAL ANY LEAD ANOMALIES. IT IS NOT KNOWN IF THERE IS AN ISSUE WITH THE ICD CONNECTION OR THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURATA STS OPTIM ACTIVE FIXATION, SJ4 CONNECTOR DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7120Q/65

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention CD2211-36Q, (B)(4)