BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2042476 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01180
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING COMPLETION OF THE DISK ANALYSIS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A PHYSICIAN CUSTOMER IS QUESTIONING THE RATE OF BATTERY DEPLETION WITH THIS DEVICE. HE REPORTED A SUDDEN DROP IN BATTERY VOLTAGE THAT WAS NOT AS EXPECTED. A MEMORY DISK WAS SENT TO BOSTON SCIENTIFIC'S INTERNAL TECHNICAL SERVICES FOR A LONGEVITY ASSESSMENT. NO ADVERSE PATIENT EFFECTS REPORTED AND THE DEVICE REMAINS IMPLANTED AND IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H230

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention