BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 1073076 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02322
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    May 7, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD DID NOT REVEAL ANY CONDITION THAT WOULD HAVE CONTRIBUTED TO THE FIELD EXPERIENCE OF PERFORATION. A TIP STIFFNESS TEST WAS PERFORMED TO ADDRESS THE REPORTED PERFORATION AND FOUND TO BE WITHIN SPECIFICATION. THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS. ALL MEASURED DATA WERE FOUND TO BE WITHIN PRODUCT SPECIFICATION.

    Description of Event or Problem · 1

    THREE WEEKS POST IMPLANT, THE PATIENT REPORTED CHEST PAIN. HIGH CAPTURE THRESHOLD AND LOW IMPEDANCE WERE NOTED. A CHEST X-RAY REVEALED THAT THE LEAD TIP AND A PORTION OF THE DISTAL SHOCKING COIL WAS IN THE PERICARDIAL CAVITY. THE LEAD WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    AT A FOLLOW-UP VISIT IN 2008, THE PATIENT REPORTED HAVING CHEST PAIN ABOUT THREE WEEKS POST IMPLANT. THE PATIENT DID NOT REPORT THE PAIN TO ANYONE UNTIL THE SAME DAY VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7002/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention