BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY

    MDR report key: 1864094 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15994
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    June 28, 2010
    Report Date
    August 9, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P050046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO RECENT INFORMATION WE RECEIVED, THE PATIENT EXPIRED AND THE CAUSE OF DEATH WAS RELATED TO TERMINAL HEART FAILURE. NO ALLEGATION WAS MADE AGAINST THE DEVICE OR LEADS; THE DEATH WAS REPORTEDLY NOT RELATED TO THE EARLIER INFECTION; AND THE PRODUCTS ARE NOT SCHEDULED TO BE RETURNED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT WAS HOSPITALIZED, DUE TO A SYSTEM-RELATED INFECTION. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4554

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death 4554| 0185| H240| 4096