BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2050725 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-04071
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, NO FURTHER INFORMATION ON THIS HAS BEEN AVAILABLE. SHOULD NEW DETAILS BE FORWARDED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FIELD REPRESENTATIVE AND PHYSICIAN CONSULTATION, OVERSENSING CONTRIBUTING TO PACING INHIBITION WAS APPARENT ON THE REVIEWED ELECTROGRAM. IT WAS FURTHER REPORTED THAT THIS PATIENT WAS PACER DEPENDANT AND THE INHIBITION PERIOD HAD BEEN GREATER THAN FOUR SECONDS. THE FIELD REPRESENTATIVE COMMUNICATED TO THE PHYSICIAN THE NEED TO BRING THE PATIENT BACK FOR FURTHER TESTING, SO AS TO DETERMINE ROOT CAUSE. 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 H190

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention