BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 2172955 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10738
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE AND AT THIS TIME, OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR EXPERIENCE ASYSTOLE FOR AN UNKNOWN PERIOD OF TIME DURING AN ANGIOPLASTY PROCEDURE. THE PATIENT HAD TO BE EXTERNALLY PACED. THE LOCAL FIELD REPRESENTATIVE (FR) SUBMITTED A SAVE TO DISK TO TECHNICAL SERVICES (TS) FOR REVIEW. DEVICE MEMORY ANALYSIS INDICATED THAT THERE WERE NO RESETS IN THE DEVICE OR ANY ABNORMAL RESPONSE DURING THE ANGIOPLASTY PROCEDURE. NO NOISE WAS NOTED. A ROOT CAUSE FOR THE ASYSTOLE DURING THE ANGIOPLASTY PROCEDURE WAS NOT ABLE TO BE DETERMINED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS. THE DEVICE REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H219

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening MISMATCH| H219| 4517| 0181| (B)(4)