BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, SJ4 CONNECTOR

    MDR report key: 1831193 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03521
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    June 27, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WAS REMOVED DUE TO INFECTION. THE PATIENT COMPLAINED OF PAIN AND SWELLING AT THE INCISION SITE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AT A ROUTINE FOLLOW UP THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD TRIGGERED END OF LIFE (EOL). THE PHYSICIAN ALLEGED THAT THE DEVICE HAD NEVER TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI). THIS DEVICE HAS BEEN IMPLANTED FOR FOUR YEARS. THE PHYSICIAN ALLEGED THAT THIS DEVICE HAD DEPLETED PREMATURELY. A DEVICE REPLACEMENT HAS BEEN SCHEDULED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 7122Q/58

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention CD2211-36Q, 698383, 1888TC/52, (B)(4)