BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUNCTUA

    MDR report key: 2241942 · Received September 9, 2011

    Report

    Report Number
    2124215-2011-15459
    Event Type
    Death
    Date Received
    September 9, 2011
    Date of Event
    August 13, 2011
    Report Date
    August 13, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT, DURING AN IMPLANT PROCEDURE, THIS DEVICE HAD GOOD ELECTRICAL MEASUREMENTS. DEFIBRILLATION THRESHOLD (DFT) TESTING WAS PERFORMED. FOLLOWING THE DFT TESTING, THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE AND RESUSCITATION WAS ATTEMPTED FOR 45 MINUTES. THE PATIENT DIED. A PULMONARY EMBOLISM WAS SUSPECTED TO BE THE CAUSE OF THE DEATH. THE PHYSICIAN REPORTED IT WAS UNKNOWN WHETHER THE PATIENT'S CONDITION OR THE PROCEDURE CONTRIBUTED TO THE EMBOLISM. THE CAUSE OF DEATH COULD NOT BE CONFIRMED, AS NO POST MORTEM EXAMINATION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUNCTUA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F050

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death F050| 0296