BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL TR

    MDR report key: 1771237 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12143
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 4, 2010
    Report Date
    June 4, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NKE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE REMAINS IMPLANTED. AS A RESULT, BOSTON SCIENTIFIC CRM IS UNABLE TO CONFIRM THE CLINICAL OBSERVATIONS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS EVENT WILL BE REOPENED IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE WAS PROVIDING A MAGNET RESPONSE WHEN THE MAGNET WAS APPLIED. NO ADVERSE PATIENT EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL TR IMPLANTABLE CHF GENERATOR NKE GUIDANT CRM CLONMEL IRELAND H120

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening 4543| 4470| 4592| H120| 4469