BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 2984543 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00502
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    January 25, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE LEAD WAS OTHERWISE NORMAL. A LEAD TIP STIFFNESS TEST WAS PERFORMED AND THE LEAD WAS FOUND TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOSS OF CAPTURE WAS OBSERVED. PRIOR TO THE SCHEDULED LEAD REVISION, THE PATIENT PRESENTED TO THE ER. A PERFORATION WAS CONFIRMED VIA X-RAY. A PERICARDIOCENTESIS AND STERNOTOMY WAS PERFORMED TO REPAIR THE PERFORATION. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89034 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7122Q/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention