BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1500T11 RF ABLATION GENERATOR

    MDR report key: 2100684 · Received May 18, 2011

    Report

    Report Number
    2030404-2011-00147
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE PERFORMING A CONCEALED BYPASS TRACT ABLATION PROCEDURE USING THE T11 GENERATOR AND A NON SJM ABLATION CATHETER, A STEAMPOP OCCURRED. FOLLOWING THE STEAMPOP, THE PT'S EGG SHOWED ST ELEVATION. A TROPONIN WAS DRAWN FOLLOWING THE PROCEDURE AND THE LEVEL WAS 0.63. THE PT RECOVERED FULLY WITHOUT ANY INTERVENTION AND LEFT THE HOSPITAL WITHOUT ANY PROBLEMS AND A NORMAL EGG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1500T11 RF ABLATION GENERATOR GENERATOR, LESION, RADIOFREQUENCY OAD ST. JUDE MEDICAL, IRVINE 85523 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other