BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 2071467 · Received April 28, 2011

    Report

    Report Number
    2124215-2011-07474
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 15, 2011
    Report Date
    April 27, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE AND OUR INVESTIGATION IS COMPLETE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    SUBSEQUENT INFORMATION FROM THE LOCAL FIELD REPRESENTATIVE INDICATED THAT THE PATIENT UNDERWENT A HEART TRANSPLANT PROCEDURE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CRT-D AND IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED NOISE ON THE RATE/SENSE CHANNEL. THE NOISE WAS OVERSENSED WHICH RESULTED IN INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND APPROXIMATELY FIVE SECONDS OF PACING INHIBITION. THE PATIENT WAS LATER BROUGHT INTO CLINIC FOR FURTHER EVALUATION. IT WAS REPORTED THAT THE PATIENT HAD A LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTED. IT WAS NOTED THAT THE PATIENT HAD NUMEROUS VENTRICULAR FIBRILLATION (VF) EPISODES IN WHICH UNDERSENSING OCCURRED AND THE PATIENT REQUIRED EXTERNAL DEFIBRILLATION. UPON DEVICE INTERROGATION FOLLOWING THE EXTERNAL SHOCKS, A MESSAGE WAS DISPLAYED INDICATING HIGH VOLTAGE DETECTION ON SHOCKING COILS. TECHNICAL SERVICES DISCUSSED THIS MESSAGE WAS DISPLAYED DUE TO AN EXTERNAL SHOCK BEING DELIVERED WHILE THE DEVICE WAS CHARGING FOR THERAPY DELIVERY. APPROXIMATELY TEN DAYS LATER, THE DEVICE WAS FOUND TO HAVE REACHED END OF LIFE. AS THE PATIENT HAS AN LVAD, THE PHYSICIAN WAS NOT CONCERNED ABOUT CARDIAC OUTPUT OR TACHYCARDIA EPISODES. TACHY THERAPY WAS ELECTIVELY PROGRAMMED OFF AND BRADY THERAPY REMAINS AVAILABLE FOR PACING SUPPORT. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN MADE. AS OF TODAY, AVAILABLE INFORMATION INDICATES THE SYSTEM REMAINS IN SERVICE.

    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 66 YR Life Threatening| R 4543| H170| 0158