BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 2041263 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-06013
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF NEW INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI) AND THE PHYSICIAN INQUIRED HOW LONG THE PRODUCT CAN REMAIN IMPLANTED POST ERI INDICATOR, AS IT HAS BEEN REPORTED THE PATIENT HAS AN INFECTION OF UNKNOWN SOURCE. THE MEDICAL FACILITY INQUIRED WITH BOSTON SCIENTIFIC TECHNICAL SERVICES, IF THE CHANGE OUT COULD BE POSTPONED UNTIL THE INFECTION IS RESOLVED. TECHNICAL SERVICES PROVIDED LABELING GUIDANCE REGARDING LONGEVITY AFTER ERI AND ENCOURAGED THE PHYSICIAN TO MOVE FORWARD WITH DEVICE REPLACEMENT. NO ALLEGATIONS AGAINST THE FUNCTIONALITY OR LONGEVITY OF THE IMPLANTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H190

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention