BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAPY COOL PATH CATHETER

    MDR report key: 2396809 · Received December 28, 2011

    Report

    Report Number
    MW5023655
    Event Type
    Injury
    Date Received
    December 28, 2011
    Date of Event
    December 28, 2011
    Report Date
    December 28, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THERAPY COOL PATH CATHETER CRACKED AND LEAKING NEAR IRRIGATION PORT. REMOVED BY PHYSICIAN. NO EVIDENCE OF INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAPY COOL PATH CATHETER EP CATHETER OAD ST. JUDE MEDICAL IBI-83327 3527903

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention