BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAZER II

    MDR report key: 3963106 · Received July 29, 2014

    Report

    Report Number
    2134265-2014-04831
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 26, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    LPB
    PMA / PMN Number
    P920047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT THE TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2014-02174, 2134265-2014-02173. IT WAS REPORTED THAT A PHRENIC NERVE DAMAGE OCCURRED. A MAESTRO 3000¿ CARDIAC ABLATION SYSTEM POD AND CONTROLLER WERE SELECTED FOR TREATMENT. DURING PROCEDURE, A NOISY FAN WAS OBSERVED FROM THE CONTROLLER. FURTHERMORE, IT WAS NOTED THAT THE POD HAD SOME LOOSE COMPONENTS INSIDE WHICH CAUSED A RATTLING SOUND. TO ENSURE THAT THE PHRENIC NERVE WAS NOT IN THE AREA OF ABLATION, THE PHYSICIAN WAS PACING FROM A 4MM BLAZER II HTD ABLATION CATHETER. HOWEVER, IT WAS NOTED THAT AN NON-BSC STIMULATOR WAS NOT PACING SO THE PHRENIC NERVE WAS NOT CAPTURED THUS THE PHRENIC NERVE WAS DAMAGED CAUSING BREATHING ISSUES TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE PATIENT'S BREATHING FUNCTION HAS IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441344 BLAZER II CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BOSTON SCIENTIFIC - COSTA RICA (COYOL) UNK45

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MAESTRO 3000¿ CARDIAC ABLATION SYSTEM - CONTROLLER| MAESTRO 3000 RF CARDIAC ABLATION POD,100| ST. JUDE EP MED STIMULATOR