BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 3053211 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04812
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    October 1, 2012
    Report Date
    March 20, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS SYSTEM REMAINS IMPLANTED AND IN SERVICE. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS DEVICE AND RIGHT VENTRICULAR LEAD DISPLAYED NOISE RESULTING IN OVERSENSING. DURING A PREVIOUS VISIT NOISE AND AN INAPPROPRIATE SHOCK HAD BEEN NOTED. IT WAS THOUGHT THERE MAY BE LEAD INSULATION DAMAGE. A DECISION WAS MADE TO FURTHER MONITOR THIS LEAD AND DEVICE. APPROXIMATELY THREE MONTHS LATER, A FOLLOW UP VISIT REVEALED THAT INAPPROPRIATE SHOCKS HAVE BEEN DELIVERED. IT WAS THOUGHT THE NOISE MIGHT BE MYOPOTENTIAL IN NATURE. SHOCK, PACING IMPEDANCE AND THRESHOLD MEASUREMENTS HAVE BEEN NORMAL AND STABLE. THE NOISE WAS NOTED IN BOTH THE PACE/SENSE AND SHOCK CHANNELS AND HAS RESULTED IN ASYSTOLE GREATER THAN TWO SECONDS. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED FOR THEIR RECOMMENDATIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155323 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND M177

    Patients

    Seq Age Sex Outcome Treatment
    1