BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1871653 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17805
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 30, 2010
    Report Date
    February 19, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS REFERRED TO THEIR ELECTROPHYSIOLOGIST WHO RECOMMENDED A LEAD REVISION PROCEDURE. THE PATIENT IS STILL CONSIDERING THEIR OPTIONS AND AS OF TODAY THE LEAD REVISION PROCEDURE HAS NOT OCCURRED. THE LEAD REMAINS IN SERVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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 LEAD BARREL NOTED NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SERIES OF AUTOMATED DIAGNOSTIC TESTING THAT VERIFIES THE PERFORMANCE OF PACING, SENSING AND SHOCKING FUNCTIONS OF THE DEVICE COMMENSURATE WITH BATTERY VOLTAGE. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. THE DEVICE MET SPECIFICATIONS. THE FIELD ALLEGATIONS WERE NOT CONFIRMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEAD OVERSENSED NOISE RESULTING IN PACING INHIBITION FOR A PACEMAKER DEPENDENT PATIENT. THE PATIENT WAS ASYSTOLE FOR APPROXIMATELY TWO CONSECUTIVE SECONDS FOR WHICH THEY WERE SYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR LWP GUIDANT CRM CLONMEL IRELAND H217

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR 1860| 0158| H217| H177| 4193| 5076| 4542