BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATCH

    MDR report key: 1870619 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17039
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 23, 2010
    Report Date
    July 11, 2012
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    NHW
    PMA / PMN Number
    P830060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT PLANNED TO BE MONITORED. THERE WERE NO PLANS FOR ADDITIONAL INTERVENTION AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION HAVE BEEN MADE. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE RETURNED LEAD SEGMENT WAS PERFORMED.THE LEAD WAS SEVERED 14.2 CM FROM THE TERMINAL PIN, AND ONLY THE PROXIMAL SEGMENT WAS RETURNED. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND TWO EPICARDIAL LARGE PATCH LEADS WERE EXHIBITING HIGH OUT OF RANGE SHOCKING IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS AND LOW OUT OF RANGE SHOCKING IMPEDANCE MEASUREMENTS LESS THAN 20 OHMS. THE EPICARDIAL PATCHES HAVE BEEN IMPLANTED FOR APPROXIMATELY 19 YEARS. A BOSTON SCIENTIFIC CRM TECHNICAL SERVICES CONSULTANT RECOMMENDED PERFORMING A 1.1 AND 41 JOULE SHOCK TO TEST THE INTEGRITY OF THE SYSTEM AND THE DEVICE'S ABILITY TO DELIVER A SHOCK. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    APPROXIMATELY TWO YEARS LATER THE EPICARDIAL PATCH WAS RETURNED FOR ANALYSIS DUE TO A PATIENT DEATH FROM CONGESTIVE HEART FAILURE.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATCH IMPLANTABLE LEAD NHW HISTORICAL CPI ST. PAUL 0041

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR 0041| 4312| 1857| 1746| 1600