BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 1952559 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23505
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 21, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS IS CURRENTLY ONGOING. ONCE ANALYSIS IS COMPLETE THIS EVENT WILL BE UPDATED AND RESUBMITTED.

    Additional Manufacturer Narrative · 1

    UPON RECEIVING THIS DEVICE AT THE (B)(4) LABORATORY, DEVICE MEMORY WAS REVIEWED. IT WAS REVEALED THAT THIS DEVICE DECLARED THE BATTERY STATUS ELECTIVE REPLACEMENT INDICATORS (ERI) ON (B)(4), 2010 AND END OF LIFE (EOL) ON (B)(4), 2010. THE DEVICE DECLARED A CHARGE TIME OUT FAULT CODE ON (B)(4), 2010 AND SUBSEQUENTLY WENT INTO STORAGE MODE ON (B)(4), 2010. THIS DEVICE WAS NOT EXPLANTED UNTIL (B)(4), 2010. THIS DEVICE IS IN STORAGE MODE DUE TO A LOW BATTERY VOLTAGE AND THEREFORE IS UNABLE TO CHARGE AND DELIVER A FULL ENERGY SHOCK. THIS DEVICE PASSED LABELED LONGEVITY. ANALYSIS CONCLUDED THIS DEVICE MET SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED AND RESUBMITTED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    SUBSEQUENTLY THIS DEVICE WAS RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE DEFIBRILLATOR DECLARED THE BATTERY STATUS END OF LIFE (EOL) SIX MONTHS AGO. CURRENTLY, THIS DEVICE IS DISPLAYING A FAULT CODE AND IS IN STORAGE MODE WITH A MONITORING VOLTAGE OF 2.1 VOLTS. IT IS INTENDED TO REPLACE THIS DEVICE IN THE NEAR FUTURE. CURRENTLY THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H175

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening 4517| 4480| H175| 0184