BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 2153244 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06584
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 14, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. ANALYSIS DETERMED THAT THE DEVICE REACHED STORAGE MODE DUE TO LOW BATTERY VOLTAGE. THE DEVICE WAS PROGRAMMED OUT OF STORAGE MODE TO VERIFY THERAPY. THE DEVICE WAS UNABLE TO CHARGE AND DELIVER A FULL ENERGY SHOCK DUE TO THE LOW BATTERY VOLTAGE AND THE INCREASED CELL IMPEDANCE AT THE END OF LIFE. THE DEVICE WAS SUBSEQUENTLY PROGRAMMED TO 5 JOULES AND THE WAS ABLE TO CHARGE AND DELIVER A 5 J SHOCK. THE DEVICE WAS EXPOSED TO AUTOMATED DIAGNOSTIC TESTS THAT VERIFIED THE PERFORMANCE OF PACING, SENSING AND RECORDING FUNCTIONS OF THE DEVICE AND NO ANOMALIES WERE FOUND. THIS DEVICE PERFORMED NORMALLY THROUGHOUT ANALYSIS, OPERATING AS DESIGNED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED AND IS CURRENTLY BEING ANALYZED. WHEN TESTING IS COMPLETE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE DECLARED END OF LIFE (EOL), THEN REACHED STORAGE MODE. A CHANGE OUT PROCEDURE WAS PERFORMED AND THE DEVICE WAS EXPLANTED AND REPLACED WITHOUT COMPLICATION. NO DEVICE PERFORMANCE ALLEGATIONS WERE REPORTED AND TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H177

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R 7278| 4480| H177| 6944| 5568| 4555