BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1954308 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24705
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 3, 2010
    Report Date
    January 13, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MOST RECENTLY, THIS DEVICE HAS BEEN EXPLANTED AND RETURNED WITHOUT ALLEGATION. BOSTON SCIENTIFIC HAS CONCLUDED IT IS UNLIKELY THAT DEVICE CHARACTERISTICS CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THIS MEDICAL DEVICE YET REMAINS IN SERVICE. THE INVESTIGATION REMAINS OPEN AT THIS TIME. AS NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), WHICH IS PART OF THE SHORTENED REPLACEMENT WINDOW ADVISORY APRIL 2007 POPULATION PRODUCT ADVISORY INITIALLY COMMUNICATED ON (B)(6) 2007, COULD NOT BE CONFIRMED OR DENIED ALLEGATION OF POTENTIAL EARLY ELECTIVE REPLACEMENT INDICATOR (ERI). THE MOST RECENT MONITORING VOLTAGE MEASUREMENT BEING 2.56 VOLTS WITH A CHARGE TIME MEASUREMENT OF 14.1SECONDS. THE BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT HAD NOT YET PROCESSED SAVE-TO-DISK ANALYSIS, AND DID RECOMMEND THE DEVICE BE EXPLANTED IMMEDIATELY SINCE THE DEVICE ALREADY APPEARED TO BE PAST ERI AND THERE WAS NO GUARANTEE OF A SAFETY MARGIN IF LIFE-SAVING THERAPY WOULD BE NEEDED. THERE WERE NO ADVERSE PATIENT SYMPTOMS ASSOCIATED WITH THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H177

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR H170| 0158| 4542| H177| 4086