BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACUITY

    MDR report key: 3813074 · Received May 15, 2014

    Report

    Report Number
    2124215-2014-10743
    Event Type
    Death
    Date Received
    May 15, 2014
    Date of Event
    October 9, 2013
    Report Date
    June 11, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P050046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THIS EVENT IS ON-GOING AS A REQUEST HAS BEEN MADE TO THE LOCAL REPRESENTATIVE FOR ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 IN (B)(6) 2014 FROM A PRODUCT EXPERIENCE REPORT (PER) FORM. THIS PATIENT WAS ADMITTED INTO THE EMERGENCY ROOM (ER) DUE TO AN INFECTION IN (B)(6) 2013. THE PATIENT WAS PRESENTED BACK TO THE ELECTROPHYSIOLOGY (EP) LABORATORY FOUR DAYS LATER AND THE DEVICE WAS EXPLANTED. THE PATIENT DIED IN (B)(6) 2013.

    Description of Event or Problem · 1

    SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE LOCAL REPRESENTATIVE THAT THE DOCUMENTED CAUSE OF THE PATIENT'S DEATH WAS SEPSIS. FROM THE PHYSICIAN'S PERSPECTIVE, THE USE OF THE DEVICE/LEAD SYSTEM AND PROCEDURE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION WHICH ULTIMATELY LED TO THE PATIENT'S DEATH. THE LOCAL REPRESENTATIVE COMMENTED THAT THE PATIENT HAD BEEN STARTED ON INTRAVENOUS ANTIBIOTICS AT THE TIME OF HOSPITAL ADMISSION AND THERE WAS NO EVIDENCE OF VEGETATION ON THE IMPLANTED LEADS. THE DEVICE AND LEADS WERE EXPLANTED AT THE TIME OF THE INVASIVE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290438 ACUITY IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4555

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| H| L| R N140| 4469| 0295| 4555