BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST. JUDE MEDICAL

    MDR report key: 1327333 · Received February 25, 2009

    Report

    Report Number
    MW5010100
    Event Type
    Injury
    Date Received
    February 25, 2009
    Date of Event
    February 24, 2009
    Report Date
    February 25, 2009
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN PLACED WIRE IN CORONARY SINUS. PHYSICIAN TRACKED LEAD OVER WIRE TO PLACE IN CORONARY SINUS AND WIRE TIP BROKE OFF IN PATIENT'S CORONARY SINUS. UNABLE TO RETRIEVE WIRE TIP AFTER REPEATED ATTEMPTS. WIRE TIP REMAINS IN PATIENT. THIS OCCURRED PERFORMING A BIVENTRICULAR ICD IMPLANT WHILE PLACING THE CORONARY SINUS LEAD. DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: BI VENTRICULAR ICD IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE MEDICAL CPS COURIER GUIDEWIRE, SOFT 0.014" 195 CM DQX ST. JUDE MEDICAL DS2G001 90011052

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization