BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST JUDE MEDICAL

    MDR report key: 1309303 · Received February 9, 2009

    Report

    Report Number
    MW5009894
    Event Type
    Injury
    Date Received
    February 9, 2009
    Report Date
    January 25, 2009
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD DUAL CHAMBER PACER IMPLANTED IN 2008 FOR TACHY BRADY SYNDROME. POST PROCEDURE, CXRS OK WITHOUT PNEUMOTHORAX. PACER CHECK OK APPROX TWO MONTHS LATER. IN EARLY 2009, PT PRESENTED WITH DYSPNEA & CXR SHOWED A PNEUMOTHORAX ON LEFT CT SCAN OF CHEST SHOWED RV LEAD HAD PERFORATED RV SEPTUM, LV APEX AND LUNG, READY TO PNEUMOTHORAX. PT REQUIRED THORACOTOMY FOR LEAD REMOVAL & REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL PACER VENTRICULAR LEAD DTB 1888TC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R