BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2053114 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04034
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 THIS PATIENT CONTACTED PATIENT SUPPORT TO REPORT THAT THIS DEVICE AND LEAD SYSTEM WERE RECENTLY IMPLANTED. THE PATIENT DEVELOPED AN INFECTION SHORTLY AFTER HOSPITAL DISCHARGE AND WAS ADMITTED TO THE EMERGENCY ROOM (ER) FOR TREATMENT. THE ISSUE WAS RESOLVED FOLLOWING A 7-DAY COURSE OF ANTIBIOTICS. THE DEVICE AND LEAD SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening E102| 0185