BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACUITY

    MDR report key: 2911572 · Received January 11, 2013

    Report

    Report Number
    2124215-2013-00830
    Event Type
    Death
    Date Received
    January 11, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 2, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    G050163
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. ALL EXPLANTED PRODUCTS HAVE BEEN REPORTED AS NOT BEING RETURNED AND NO ALLEGATIONS FROM THE PHYSICIAN AGAINST ANY BOSTON SCIENTIFIC PRODUCTS WERE REPORTED. THIS INVESTIGATION SHALL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD DISLODGED AND A REVISION PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, THE LV LEAD WAS SUCCESSFULLY EXPLANTED; HOWEVER, DURING SUBSEQUENT CORONARY SINUS CANNULATIONS, THE VENOGRAM IMAGE SHOWED EVIDENCE OF VESSEL PERFORATION AND THE PATIENT THEN WENT INTO SUDDEN VENTRICULAR FIBRILLATION (VF). SEVERAL EXTERNAL SHOCKS WERE FIRST ATTEMPTED; HOWEVER, THE ARRHYTHMIA FAILED TO CONVERT. THE ASSOCIATED CHRONIC DEVICE THEN DELIVERED A 41 JOULE SHOCK, SHOWING RECOVERY OF NORMAL SINUS RATE. AFTER A FEW MINUTES THE RATE OF VF RETURNED AND AGAIN THE DEVICE DELIVERED EFFECTIVE 41 JOULE SHOCKS. LIFESAVING DRUGS ALONG WITH BLOOD TRANSFUSIONS WERE ADMINISTERED BUT SHOWED NO IMPROVEMENT. THE PATIENT FAILED TO DEMONSTRATE SPONTANEOUS BREATHING AND NO PULSE ACTIVITY WAS OBSERVED FROM THEIR RADIAL OR FEMORAL, ARTERIES. THE PATIENT THEN WENT INTO COMPLETE ASYSTOLE WITH NO CAPTURED SPIKES IN THE RIGHT ATRIUM OR VENTRICLE. MEDICAL INTERVENTION CEASED AND THE PATIENT WAS PRONOUNCED DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19024 ACUITY IMPLANTABLE HF LEAD OJX CPI - DEL CARIBE 4592

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L| R