BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2173710 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11292
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 21, 2011
    Report Date
    September 25, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS IN CHEMOTHERAPY TREATMENT THEREFORE THE PRODUCT REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE CLINICALLY OBSERVED ERROR MESSAGE WAS REPRODUCED. MEMORY REVIEW CONFIRMED THAT THE DEVICE UNDERWENT A RESET DUE TO MEMORY CORRUPTION WHICH RESULTED IN THE OBSERVED ERROR MESSAGE. FOLLOWING THE RESET, THE DEVICE REVERTED TO A SAFETY MODE WITH LIMITED PROGRAMMABILITY, IN WHICH SINGLE CHAMBER PACING AND DEFIBRILLATION THERAPY WERE AVAILABLE. LABORATORY ANALYSIS CONCLUDED THAT THE MEMORY CORRUPTION THAT RESULTED IN THE DEVICE OPERATING IN FALL BACK MODE WAS A RESULT OF RADIATION THERAPY THAT WAS APPLIED TO THE DEVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT UPON INTERROGATION OF THIS DEVICE A RED SCREEN INDICATED THE DEVICE WAS LIMITED TO ONE ZONE. TECHNICAL SERVICES WAS CONTACTED AND STATED THAT THIS WAS SAFETY MODE. THE PATIENT WAS BEING TREATED WITH CHEMOTHERAPY FOR CANCER TREATMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT PASSED AWAY APPROXIMATELY FOUR YEARS LATER. THERE WAS NO ADDITIONAL INFORMATION LINKING THE DEVICE TO THE PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR LWP GUIDANT CRM CLONMEL IRELAND H215

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR 4525| H215| 4518| 4136