BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONTAK RENEWAL 3 IS-1/DF-1/LV-1

    MDR report key: 1606278 · Received February 10, 2010

    Report

    Report Number
    2124215-2009-25879
    Event Type
    Other
    Date Received
    February 10, 2010
    Date of Event
    November 5, 2009
    Report Date
    June 18, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z-1192-06 THRU Z-1194-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THIS MEDICAL DEVICE REMAINS ACTIVELY IN SERVICE. AS NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED. MOST RECENTLY, THIS MEDICAL DEVICE HAS BEEN RETURNED TO THE BOSTON SCIENTIFIC CRM POST MARKET QUALITY ASSURANCE LABORATORY BUT ANALYSIS REMAINS INCONCLUSIVE TO DATE. AS NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED. MOST RECENTLY, THIS MEDICAL DEVICE HAS BEEN RETURNED TO THE BOSTON SCIENTIFIC CRM POST MARKET QUALITY ASSURANCE LABORATORY BUT ANALYSIS REMAINS INCONCLUSIVE TO DATE. AS NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED. ANALYSIS WAS SUBSEQUENTLY PERFORMED AT OUR POST MARKET QUALITY ASSURANCE LABORATORY. PORTIONS OF THE CIRCUITRY, INCLUDING THE BATTERY, WERE ISOLATED AND TESTED. FINAL ANALYSIS CONCLUDED THAT THIS DEVICE HAD A COMPROMISED LOW-VOLTAGE CAPACITOR, WHICH RESULTED IN A HIGH CURRENT CONDITION. THIS ISSUE IS DISCUSSED IN THE Q2 2010 PRODUCT PERFORMANCE REPORT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), WHICH IS PART OF THE SHORTENED REPLACEMENT WINDOW ADVISORY APRIL 2007 POPULATION PRODUCT ADVISORY WAS INITIALLY COMMUNICATED ON 4/5/2007, DISPLAYED A MONITORING VOLTAGE MEASUREMENT OF 2.54 VOLTS AND IT WAS UNKNOWN AS TO WHEN MOL2 HAD OCCURRED. THERE WAS A CONCERN THAT THE BATTERY DEPLETED EARLIER THAN EXPECTED. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL 3 IS-1/DF-1/LV-1 IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H175 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR