BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 1871600 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-18151
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 26, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z-1192-06 THRU Z-1194-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ALLEGATION AGAINST DEVICE FUNCTIONALITY AND DUE TO THIS, ANALYSIS IS NOT REQUIRED. THE SYSTEM WAS EXPLANTED SECONDARY DUE TO PATIENT INFECTION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE SYSTEM WAS EXPLANTED SECONDARY DUE TO POCKET INFECTION. A NEW BOSTON SCIENTIFIC CRM DEVICE SYSTEM MAY BE IMPLANTED ONCE THE PATIENT IS CLEARED BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H175

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR H175| 4518| 0184| 4470