BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1946116 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20358
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    October 15, 2010
    Report Date
    May 2, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO ADDITIONAL INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE SUBSEQUENTLY WAS EXPLANTED AFTER THE PATIENT PASSED AWAY. THERE WERE NO ALLEGATIONS THAT THE DEVICE WAS ASSOCIATED WITH THE PATIENT'S DEATH. THIS DEVICE MET SPECIFICATIONS IN TESTING AND ANALYSIS. UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, INITIAL REVIEW OF RECORDED OPERATIONAL DATA SHOWED THIS DEVICE DID NOT REACH ELECTIVE REPLACEMENT STATUS. THE DEVICE WAS THEN PUT THROUGH AND PASSED A SERIES OF AUTOMATED DIAGNOSTIC TESTS THAT VERIFIED THE PERFORMANCE OF THE DEFIBRILLATION, PACING, SENSING, HIGH-VOLTAGE SHOCKING, AND RECORDING FUNCTIONS OF THE DEVICE. MICROSCOPIC VISUAL INSPECTIONS NOTED TOOL MARKS ON THE DEVICE CASING. ALL SEAL PLUGS WERE INTACT, AND ALL SETSCREWS MOVED FREELY AND OPERATED NORMALLY. LEAD IMPEDANCE TESTING WAS PERFORMED WITH A KNOWN ELECTRICAL LOAD, AND THE RESULTING MEASUREMENTS WERE NORMAL. THE DEVICE WAS THEN PUT THROUGH AND PASSED A SERIES OF AUTOMATED DIAGNOSTIC TESTING. OUR ANALYSIS AND TESTING COULD NOT CONFIRM THE REPORTED NOISE OR OVERSENSING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM A BOSTON SCIENTIFIC FIELD REPRESENTATIVE THAT DURING A ROUTINE CLINICAL FOLLOW-UP, REVIEW OF STORED ELECTROGRAMS FROM THIS DEVICE SHOWED A ONE-TIME DIVERTED VENTRICULAR FIBRILLATION EPISODE WITH APPROXIMATELY SIX SECONDS OF PACING INHIBITION DUE TO HIGH-FREQUENCY NOISE ON THE RIGHT VENTRICULAR RATE/SENSE CHANNEL. LEAD DIAGNOSTICS WERE NORMAL. THE PATIENT IS NOT PACING-DEPENDENT, AND THERE WERE NO ADVERSE EFFECTS. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT (TS) DISCUSSED THE LIKELIHOOD OF MYOPOTENTIAL OVERSENSING WITH A VAGAL RESPONSE. THE DEVICE REMAINS IMPLANTED AND 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 69 YR 0185| 4542| H217| 4470