BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2053311 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-05474
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL TESTING OF THE DEVICE REVEALED SHOCK THERAPY WAS NOT AVAILABLE. VISUAL INSPECTION OF THE DEVICE FOUND NO ANOMALIES. IMPEDANCE MEASUREMENTS WERE PERFORMED, REVEALING THE DEVICE OUTPUT CIRCUITRY WAS SHORTED. REVIEW OF DEVICE MEMORY CONCLUDED THE DEVICE EITHER DELIVERED A SHOCK TO A COMPROMISED LEAD, OR NO LEAD WAS CONNECTED AT THE TIME OF THE SHOCK, CAUSING DAMAGE TO THE OUTPUT CIRCUITRY. ANALYSIS WAS UNABLE TO DETERMINE WHETHER THE DEVICE HAD THERAPY AVAILABLE PRIOR TO EXPLANT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS RETURNED WITH NO REPORTED PRODUCT PERFORMANCE ISSUES. INITIAL ANALYSIS COMPLETED IN OUR POST MARKET QUALITY ASSURANCE LABORATORY IDENTIFIED A PRODUCT PERFORMANCE ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H197

    Patients

    Seq Age Sex Outcome Treatment
    1