BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1042343 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34298
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 11, 2008
    Report Date
    July 22, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z1192/94-6
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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 CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND LEFT VENTRICULAR (LV) TRANSVENOUS LEAD HAD PACING LEAD IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS AND NO LV CAPTURE. ADDITIONALLY, THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK FOR ATRIAL FIBRILLATION (AF). A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT DISCUSSED USING ELECTRONIC REPOSITIONING TO ADDRESS THE LV LEAD ISSUE AND USING STABILITY AT 30 MILLISECONDS TO ADDRESS THE AF ISSUE. SUBSEQUENT INFORMATION STATED THAT THE LV LEAD WAS PROGRAMMED OFF AND THE LOWER RATE LIMIT WAS CHANGED TO 40 BEATS PER MINUTE. THE PATIENT WAS ALSO PUT ON A DIURETIC TO HELP WITH THEIR HEART FAILURE SYMPTOMS. NO FURTHER TROUBLESHOOTING HAS BEEN PERFORMED AT THIS TIME. SUBSEQUENT INFORMATION INDICATES THAT THIS LV LEAD HAD FRACTURE DUE TO THE IMPEDANCE MEASUREMENT READINGS. THE PATIENT WAS TO UNDERGO A REVISION PROCEDURE IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H175 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other THE DEVICE 4517/429410 WAS IMPLANTED 23-APR-2007| THE DEVICE 0185/137639 WAS IMPLANTED 23-APR-2007| THE DEVICE 6481 035784 WAS USED DURING THE EVENT.| THE DEVICE (B)(4) WAS USED DURING THE EVENT.| THE DEVICE (B)(4) WAS IMPLANTED (B)(6) 2007| THE DEVICE (B)(4) WAS IMPLANTED (B)(6) 2007