BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST. JUDE MEDICAL

    MDR report key: 1633061 · Received March 13, 2010

    Report

    Report Number
    MW5015145
    Event Type
    Injury
    Date Received
    March 13, 2010
    Date of Event
    February 2, 2010
    Report Date
    March 13, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS PT HAD AN ICD IMPLANTED FOR PRIMARY PREVENTION OF SUDDEN CARDIAC DEATH ON (B) (6) 2010. THE DEVICE IMPLANTED WAS A ST JUDE MEDICAL SINGLE CHAMBER ICD - MODEL CD1211-36Q; (B) (4)- WITH A ST JUDE MEDICAL RIATA DURATA LEAD - MODEL 7120Q/58; (B) (4) -. THE ICD LEAD WAS IMPLANTED IN THE RV APEX IN THE USUAL MANNER. THE LEAD WAS A SCREW IN LEAD. IMPLANT PARAMETERS WERE NORMAL. THE PT PRESENTED ON (B) (6) 2010 WITH CHEST PAIN AND SHORTNESS OF BREATH. ON THE NEXT DAY, HE DEVELOPED HYPOTENSION AND WAS FOUND TO HAVE LEFT HEMOTHORAX AND LEFT PERICARDIAL EFFUSION. A CHEST TUBE AND PERICARDIAL DRAINS WERE INSERTED. CT SCAN CONFIRMED THAT THE ICD LEAD HAD PERFORATED INTO THE LEFT CHEST. TRANSFUSION WAS ADMINISTERED. THE PT HAD THE LEAD WITHDRAWN AND REPOSITIONED WITHOUT ANY COMPLICATIONS AND LEFT THE HOSPITAL ABOUT 1 WEEK LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE MEDICAL RIATA DURATA ICD LEAD LWS ST. JUDE MEDICAL 7120Q NA
    2 ST. JUDE MEDICAL SINGLE CHAMBER ICD LWS ST. JUDE MEDICAL CD1211-36Q

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L