BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2051995 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-04118
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    January 31, 2006
    Report Date
    February 22, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE SYSTEM WAS REMOVED DUE TO AN INFECTION; THEREFORE LABORATORY ANALYSIS IS NOT REQUIRED. SHOULD ANY ADDITIONAL INFORMATION RELATED TO THIS EVENT BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RETAINED LEGAL COUNCIL. ADDITIONAL INFORMATION PROVIDED STATED THAT THIS DEVICE SYSTEM WAS REMOVED DUE TO AN INFECTION.

    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 46 YR Required Intervention 0158| H177| 4470| 4542