BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1851834 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14258
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    May 24, 2010
    Report Date
    July 7, 2010
    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

    THERE WERE NO ADVERSE EVENTS REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION IN (B)(6) 2010 THAT BOSTON SCIENTIFIC'S MEDICAL RECORDS DEPARTMENT RECEIVED A CALL FROM THIS PATIENT. THE PATIENT REPORTED THAT THE IMPLANTED DEVICE AND LEAD SYSTEM WERE EXPLANTED, DUE TO INFECTION IN (B)(6) 2010.

    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 62 YR Hospitalization| R 4592| 0185| E110| 4555| MISMATCH| 4470