BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 1043468 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33173
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 4, 2008
    Report Date
    June 7, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z47/55-07
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS ANALYZED. VISUAL INSPECTION NOTED THAT THE HEADER WAS LOOSE AND ONE SEAL PLUG WAS MISSING. AN X-RAY WAS TAKEN OF THE DEVICE AND THE HEADER WIRES WERE FOUND TO BE INTACT. ALL OTHER SEAL PLUGS WERE INTACT AND ALL SETSCREWS MOVED FREELY. THE TECHNICIANS USED AN ENGINEERING-LEVEL LONGEVITY PREDICTION CALCULATION TO ASSESS THE RATE OF BATTERY DEPLETION, GIVEN THE PROGRAMMED PARAMETERS AND OTHER DATA STORED WITHIN THE MEMORY OF THE DEVICE. THE RESULTS OF THIS CALCULATION INDICATED THAT THE ACTUAL RATE OF BATTERY DEPLETION FELL WITHIN AN ACCEPTABLE RANGE. NEXT, A COMPREHENSIVE SERIES OF DIAGNOSTIC TESTS WERE CONDUCTED THAT VERIFIED THE PERFORMANCE OF THERAPY DELIVERY, SENSING, AND RECORDING FUNCTIONS. HAVING MET THE ENGINEERING LONGEVITY PREDICTION, FUNCTIONALLY PASSING ALL RETURNED PRODUCT TESTING, AND WITH NO FURTHER INFORMATION TO INDICATE A PRODUCT PERFORMANCE ISSUE, WE HAVE CONCLUDED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION. THE DAMAGE OBSERVED WITH THE HEADER IS CONSISTENT WITH INDUCED DAMAGE THAT MOST LIKELY OCCURRED DURING THE EXPLANTATION PROCEDURE. ALTHOUGH EVIDENCE INDICATES EXTERNAL STRESS MAY HAVE BEEN A FACTOR IN CAUSING THE HEADER TO BECOME LOOSE, THE ROOT CAUSE OF THE ABNORMALITY WAS ISOLATED TO INSUFFICIENT BONDING BETWEEN THE MEDICAL ADHESIVE AND THE TITANIUM CASING. MANUFACTURING ENHANCEMENTS WERE IMPLEMENTED IN 2003 TO MAKE THE BOND MORE ROBUST. THE ENHANCEMENTS HAVE DECREASED REPORTS OF THIS TYPE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), WHICH WAS PART OF THE SHORTENED REPLACEMENT WINDOW ADVISORY, ORIGINALLY COMMUNICATED APRIL 05, 2007, HAD A MONITORING BATTERY VOLTAGE OF 2.64 V AFTER 21 MONTHS OF IMPLANT. THE PHYSICIAN REPORTED THAT THE DEVICE'S FOLLOW-UPS WILL INTENSIFY TO MONTHLY. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. AT A LATER DATE, THIS CRT-D WAS EXPLANTED AND RETURNED FOR LABORATORY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H195 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R THE DEVICE 0148/(B)(4) WAS IMPLANTED (B)(6) 2006| THE DEVICE 0148/112151 WAS IMPLANTED 15-MAY-2006| THE DEVICE 4480/200894 WAS IMPLANTED 15-MAY-2006| THE DEVICE 4512/301177 WAS IMPLANTED 15-MAY-2006| THE DEVICE 4512/(B)(4) WAS IMPLANTED (B)(6) 2006| THE DEVICE 4480/(B)(4) WAS IMPLANTED (B)(6) 2006