BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 1881334 · Received October 25, 2010

    Report

    Report Number
    2124215-2010-17803
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    August 30, 2010
    Report Date
    June 28, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z-0863-05
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS THAT THE DEVICE REMAINS IN-SERVICE. THE EVENT WILL BE

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS ELECTIVELY EXPLANTED AND REPLACED IN (B)(4) 2011. THERE WERE NO ADVERSE EVENTS REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CLINIC NURSE CONTACTED TECHNICAL SERVICES TO REPORT THAT THIS DEVICE'S MONITORING VOLTAGE WAS 2.54 VOLTS. IN (B)(6) 2008 AND (B)(6) 2007, THE MONITORING VOLTAGE WAS 2.60 AND 2.94 VOLTS RESPECTIVELY. TECHNICAL SERVICES PERFORMED AN ENGINEERING CALCULATION AND THE ESTIMATED LONGEVITY WAS LESS THAN ONE YEAR. TECHNICAL SERVICES RECOMMENDED AN IN-CLINIC FOLLOW-UP IN ONE MONTH. AT THAT TIME, THE CLINIC NURSE SHOULD PERFORM A SAVE-TO-DISK FOR RETURN AND ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H215

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R 4517| 0184| H215| 4469