BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLAZER II

    MDR report key: 507345 · Received January 21, 2004

    Report

    Report Number
    2939222-2004-00004
    Event Type
    Other
    Date Received
    January 21, 2004
    Date of Event
    January 6, 2004
    Report Date
    January 8, 2004
    Manufacturer
    EP TECHNOLOGIES, INC.
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT REPORTED TO HAVE LOST SOME MOBILITY IN THEIR RIGHT ARM TWO HOURS FOLLOWING RF ABLATION TO TREAT ATRIAL FIBRILLATION AND ISTHMUS FLUTTER. A CT SCAN DID NOT SHOW ANY INJURY AND THE PT WAS CLEARED BY NEUROLOGY. THE PT IS CURRENTLY FINE AND HAS NO KNOWN CONSEQUENCES FROM THE EVENT. IT IS SUSPECTED THE PT SUFFERED A STROKE THAT RESOLVED ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAZER II THERAPEUTIC ABLATION CATHETER LPB EP TECHNOLOGIES, INC. 4790THK2 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other BLAZER II XP ABLATION CATHETER 2004,| LONG SHEATH (MFR UNK), 2004.| 800TC RF GENERATOR, 2004,| ESI NAVIGATION SYSTEM 2004,| 9900 ICE INTRACARDIAC ULTRASOUND CATHETER, 2004,