BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 2050741 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03206
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    January 17, 2011
    Report Date
    June 2, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION HAS BEEN RECEIVED THAT THIS DEVICE HAS BEEN EXPLANTED AND SUCCESSFULLY REPLACED.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED AND/OR UPON DEVICE RETURN.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT CONTACTED PATIENT SUPPORT TO REPORT THAT THE DEVICE WAS GENERATING BEEPING TONES. PATIENT SUPPORT RECOMMENDED A CALL TO THE PHYSICIAN TO DISCUSS FURTHER. SUBSEQUENTLY, THE LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO REPORT THAT THIS DEVICE HAD TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI) BACK IN (B)(6) 2010. THE PATIENT HAD BEEN LOST TO FOLLOW UP. THE DEVICES MONITORING VOLTAGE WAS 2.54 VOLTS ASSOCIATED WITH A CHARGE TIME OF 25.1 SECONDS. THE PATIENT HAS BEEN SCHEDULED FOR A REPLACEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H179

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR T125| 4087| 0158| H179