BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 2052641 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03849
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 1, 2011
    Report Date
    May 5, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A NEW DEVICE WAS SUCCESSFULLY IMPLANTED. TO DATE, THE EXPLANTED DEVICE HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. UPON RECEIPT, THE DEVICE WILL UNDERGO DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS RECEIVED AT MIDDLE OF LIFE 2 (MOL2) BATTERY STATUS, WITH A MONITORING VOLTAGE OF 2.60 VOLTS. A REVIEW OF DEVICE MEMORY REVEALED THE DEVICE HAD REVERTED TO SAFETY FALLBACK MODE ON (B)(6) 2011 AFTER RECORDING THREE MEMORY ERRORS. LABORATORY TECHNICIANS RESTORED THE DEVICE FUNCTIONALITY, AND THE DEVICE PASSED ALL MANUAL DEFIBRILLATION, PACING, AND SENSING TESTS. LABORATORY ANALYSIS WAS NOT ABLE TO DETERMINE THE CAUSE OF THE MEMORY CORRUPTION. HOWEVER, BY REVERTING TO A SAFETY MODE, AS DESIGNED, THE DEVICE CONTINUED TO PROVIDE LIFE SAVING BRADY AND TACHY THERAPY WHILE IMPLANTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR REVEALED A FAULT CODE MESSAGE THAT STATED: "WARNING: A PULSE GENERATOR FAULT HAS OCCURRED. DEVICE FUNCTIONALITY IS PERMANENTLY LIMITED TO A SINGLE ZONE SHOCK ONLY CONFIGURATION. TACHY RATE AND DURATION REMAIN PROGRAMMABLE. PACING IS NON-PROGRAMMABLE. THERAPY HISTORY AND DIAGNOSTICS ARE UNAVAILABLE. THE DEVICE HAD ENTERED SAFETY FALLBACK MODE FOR AN UNKNOWN REASON. THE DEVICE WAS REMOVED, REPLACED, AND RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H190

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R