BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2042389 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01170
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 27, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE 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

    ANALYSIS OF THE RETURNED PRODUCT IS CURRENTLY ONGOING. THIS EVENT WILL BE UPDATED UPON COMPLETION OF THE ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE, WHICH WAS INCLUDED IN THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS PRODUCT UPDATE CLASSIFIED AS A PRODUCT ADVISORY WAS INITIALLY COMMUNICATED ON (B)(6) 2007, TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI). MONITORING VOLTAGE WAS 2.63 VOLTS AT 39 MONTHS OF IMPLANT. THE PATIENT WAS TO SEE THE PHYSICIAN TO SCHEDULE A REPLACEMENT PROCEDURE. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    THE DEVICE WAS LATER EXPLANTED FOR NORMAL BATTERY DEPLETION. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION. THE DEVICE WAS RETURNED FOR RELIABILITY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H170

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR 0184| H170| 4470| 4543| 4549