BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 1862132 · Received October 8, 2010

    Report

    Report Number
    2124215-2010-18492
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 28, 2010
    Report Date
    December 9, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z-1047-2007 TO Z-1055-20
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, LABORATORY TECHNICIANS UTILIZED 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 PACING, 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.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATES THAT THE DEVICE WAS EXPLANTED. THE DEVICE HAS BEEN RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT MONTHLY FOLLOW UPS AND REPLACEMENT WITH IN THIRTY DAYS OF THE DEVICE DECLARING ELECTIVE REPLACEMENT INDICATOR (ERI) WAS RECOMMENDED BY A TECHNICAL SERVICES (TS) CONSULTANT FOR THIS CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D). THE DEVICE IS A PART OF THE SHORTENED REPLACEMENT WINDOW (4/05/2007) ADVISORY. INFORMATION REGARDING THE 27 MONTH BATTERY VOLTAGE IS UNKNOWN. AT THIS TIME, IT IS UNABLE TO BE DETERMINED IF THE DEVICE IS EXHIBITING SRW BEHAVIORS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. 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 H217

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR 4548| 6949| 4542| H177| 5076| 4479| H120| 4543| H217| 0184