BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 2173232 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11077
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 16, 2011
    Report Date
    July 12, 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

    THE DEVICE WAS RETURNED AND IS CURRENTLY IN ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE PRODUCT WAS PERFORMED. THE MEASURED BATTERY VOLTAGE WAS LOWER THAN EXPECTED. AN EXTERNAL POWER SUPPLY WAS CONNECTED TO THE DEVICE AND THE ELECTRICAL CURRENT WAS MONITORED. DURING THE MONITORING PROCESS A HIGHER THAN NORMAL CURRENT DRAIN WAS OBSERVED. ELECTRICAL TESTING AND ANALYSIS WERE THEN CONDUCTED, WHICH ISOLATED THE HIGH CURRENT CONDITION TO AN ANOMALY ON ONE OF THE COMPONENT LAYERS (GATE OXIDE) WITHIN THE DEVICE'S INTEGRATED CIRCUIT. THIS ANOMALY CAUSES A HIGH CURRENT DRAIN, WHICH OVER TIME RESULTS IN PREMATURE BATTERY DEPLETION. LABORATORY TECHNICIANS CONCLUDED THAT THIS ANOMALY FOUND DURING ANALYSIS LIKELY CONTRIBUTED TO THE CLINICAL OBSERVATIONS DUE TO THE STATE OF THE BATTERY CONDITION AND THE HIGH CURRENT CONDITION FOUND WITHIN THE INTERNAL CIRCUITRY.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXHIBITING HIGH OUT OF RANGE LEAD IMPEDANCE MEASUREMENTS ON THE ATRIAL, RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) CHANNELS. DATA SHOWED THAT ALL MEASUREMENTS WERE STABLE AND THEN CHANGED TO OUT OF RANGE MEASUREMENTS ALL ON THE SAME DAY. THE LOCAL AREA SALES REPRESENTATIVE NOTED THAT THE DEVICE WAS NOT ABLE TO PACE, HOWEVER SENSING WAS NORMAL. THE DEVICE WAS SUBSEQUENTLY REMOVED FROM THE PATIENT AND THE LEADS WERE RE-TESTED WITH THE PACING SYSTEM ANALYZER (PSA) AND NORMAL IMPEDANCES MEASUREMENTS WERE OBSERVED. A NEW DEVICE WAS IMPLANTED WITH THE ORIGINAL LEADS, AND AGAIN, ALL IMPEDANCES TESTED NORMAL. THE EXPLANTED DEVICE IS SCHEDULED TO BE 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 H217

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R 1298| (B)(4)| H217| 0181| MISMATCH| 1190