BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 1864070 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15903
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 6, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE NATURE OF THE ISSUE, NO ANALYSIS WILL BE CONDUCTED IF THE PRODUCT IS EXPLANTED AND RETURNED. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS PRODUCT HAD AN INFECTION. IT WAS REPORTED THAT THE INCISION HAD COME OPEN AND BECAME RED AND SWOLLEN. ANTIBIOTICS WERE PRESCRIBED, HOWEVER THE PATIENT HAD AN ADVERSE REACTION AND HAD TO BE HOSPITALIZED. THE PATIENT REPORTED THE INFECTION HAS NOT YET BEEN RESOLVED, AND DID NOT THINK ANOTHER PROCEDURE COULD BE PERFORMED DUE TO THEIR CURRENT HEALTH STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK ENDURANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0154

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization 4440| 4538| 1851| H170| 0154