BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1870626 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17010
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    July 17, 2010
    Report Date
    August 24, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z-0047-2008 TO Z-0053-20
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE WAS EMITTING BEEPING TONES IN AN ATYPICAL PATTERN. AFTER FURTHER DISCUSSION WITH PATIENT SERVICES, THE PATIENT THOUGHT THE TONES WERE COMING FROM HIS COMPUTER. IT WAS LATER REPORTED THAT THE DEVICE REACHED END OF LIFE (EOL) DUE TO EXTENDED CHARGE TIME. MONITORING VOLTAGE WAS 2.4 VOLTS. THIS DEVICE IS INCLUDED IN THE MID LIFE DISPLAY OF REPLACEMENT INDICATORS ADVISORY POPULATION. DEVICE REPLACEMENT WAS PLANNED. NO ADVERSE PATIENT EFFECTS HAVE BEEN 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 66 YR H175| 4518| 4087| 0185