BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3041155 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01236
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 16, 2010
    Report Date
    January 10, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE PATIENT IMPLANTED WITH THIS DEVICE SYSTEM SUFFERED FROM AN INFECTION. THE PATIENT ADVOCATE REPORTED THAT AN OPEN HEART SURGERY PROCEDURE WAS PERFORMED TO EXTRACT THE DEVICE SYSTEM. IT WAS ALSO REPORTED THAT AS A RESULT OF THE INFECTION, EYE DAMAGE AND BRAIN BLEEDING HAD OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143405 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R 0184| 4469| E110