BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1953710 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-23885
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED AT THIS TIME, 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 DUE TO A PATIENT INFECTION THE SYSTEM WAS EXTRACTED. THE PHYSICIAN ATTEMPTED TO REMOVAL THIS LEAD BUT EXPERIENCED DIFFICULTY SO THE LEAD WAS SURGICALLY ABANDONED AND THIS PATIENT WAS REFERRED FOR EXPLANT LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention 0158| N119| 4136| 4543