BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 2051690 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03366
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 21, 2011
    Report Date
    March 24, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE PHYSICIAN BROUGHT THE PATIENT INTO THE ELECTROPHYSIOLOGY LAB AND TESTED THE DEVICE SYSTEM. THE PATIENT WAS GIVEN CONSCIOUS SEDATION AND A SHOCK ON T WAS PERFORMED TO INDUCE VENTRICULAR FIBRILLATION (VF). THE DEVICE APPROPRIATELY DETECTED THE VF AND CONVERTED THE RHYTHM TO NORMAL SINUS RHYTHM WITH THE DELIVERY OF ONE 15 JOULE SHOCK. ALL LEAD IMPEDANCES AND THRESHOLD MEASUREMENTS WERE ASSESSED AND FOUND TO BE SATISFACTORY. A REMOTE MONITORING INTERROGATION THREE DAYS LATER INDICATED NORMAL LEAD FUNCTION. THE ISSUE APPEARED TO BE RESOLVED.

    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.

    Additional Manufacturer Narrative · 1

    APPROXIMATELY TWO MONTHS LATER, WE RECEIVED ANOTHER LATITUDE REMOTE MONITORING ALERT THAT THIS CRT-D AND RV LEAD WERE AGAIN EXHIBITING A LESS THAN 20 OHMS SHOCK LEAD IMPEDANCE MEASUREMENT. ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION HAVE BEEN MADE. AT THIS TIME, THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION RECEIVED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION (NBD). NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM LATITUDE REMOTE MONITORING THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED A LOW SHOCK LEAD IMPEDANCE. THE SHOCK LEAD IMPEDANCES HAD HISTORICALLY BEEN IN RANGE AND WERE BACK TO NORMAL RANGE (40-50 OHMS) SINCE THE OCCURRENCE OF THE OUT OF RANGE MEASUREMENT. ADDITIONAL INFORMATION FROM THE LOCAL AREA SALES REPRESENTATIVE INDICATED THE CLINIC WAS AWARE AND PLANNED TO MONITOR THE PATIENT VIA LATITUDE. THERE ARE NO PLANS FOR ADDITIONAL INTERVENTION AT THIS TIME. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR LWP GUIDANT CRM CLONMEL IRELAND H210

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Life Threatening| R 4592| 4543| H210| 0144| 1861| 1851| 4469| 4015