BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, SJ4 CONNECTOR

    MDR report key: 1830584 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03423
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    November 25, 2009
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP950022
    Removal / Correction Number
    NA
    Adverse Event
    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. REVIEW OF QUALITY RECORDS.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED TO THE CLINIC WITH A HEMATOMA AT THE POCKET SITE AND INFECTION. THE PROBLEM WAS RESOLVED WITH MEDICATION. HOWEVER, IT WAS LATER REPORTED THAT THE POCKET WAS REOPENED AND ICD SYSTEM WAS EXPLANTED..

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention CD2211-36Q (B)(4)