BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 3210211 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07961
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    January 14, 2011
    Report Date
    May 16, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY AN INTERROGATION WITH THE PROGRAMMER INDICATED THE BATTERY VOLTAGE WAS 1.18V, AND A FULL MEMORY DUMP WAS NOT ABLE TO BE COMPLETED. THE DEVICE WAS AT BATTERY EXPIRED (BEX) AT EXPLANT, AND THERAPY WAS NOT AVAILABLE. IT WAS NOTED THAT END OF LIFE (EOL) WAS DECLARED APPROXIMATELY FOURTEEN MONTHS PRIOR TO BEX. DEVICE LONGEVITY CALCULATIONS WERE DONE AND THE DEVICE MET LONGEVITY EXPECTATIONS BASED ON THE PROGRAMMED OUTPUTS AND USAGE. TONES COULD NOT BE CONFIRMED THROUGH ANALYSIS, HOWEVER, IT IS NORMAL DEVICE BEHAVIOR TO EMIT TONES WHEN ELECTIVE REPLACEMENT INDICATOR (ERI) IS REACHED. ANALYSIS OF THE SETSCREWS WAS PERFORMED AND THEY MOVED FREELY AND THERE WAS NO DIFFICULTY IN REMOVING THE LEADS FROM THE HEADER. BOTH THE RA AND RV TIP SETSCREWS WERE IN THE DOWN POSITION UPON RETURN AND SECURING THE LEAD TIPS. IT WAS SUSPECTED THAT THE SETSCREWS MAY HAVE BEEN OVERLOOKED DURING THE EXPLANT PROCEDURE AND WERE THE REASON THE LEADS COULD NOT BE REMOVED. OVERALL, THE DEVICE MET LONGEVITY AND THE OBSERVATIONS RELATED TO THE SETSCREWS COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HEARD BEEPING TONES. DEVICE EVALUATION WAS DONE AND IT WAS DETERMINED THE DEVICE REACHED END OF LIFE (EOL) BATTERY STATUS AT THE BEGINNING OF THE YEAR. THE DEVICE WAS CURRENTLY IN STORAGE MODE WITH A MONITORING VOLTAGE OF 1.65 VOLTS AND A CHARGE TIME OF 37.4 SECONDS. SURGICAL INTERVENTION WAS PERFORMED AND THE RIGHT ATRIAL (RA) LEAD AND THE RIGHT VENTRICULAR (RV) RATE/SENSE PORTION WERE STUCK IN THE HEADER AND SET SCREWS OF THIS DEVICE. ATTEMPTS WERE MADE TO FREE THE LEADS, BUT THEY WERE UNSUCCESSFUL AND THE PHYSICIAN CUT THE RA LEAD AND THE RV LEAD'S RATE/SENSE PORTION AND SURGICALLY ABANDONED THEM. THIS DEVICE WAS THEN EXPLANTED. A NEW DUAL CHAMBER ICD WAS IMPLANTED, AND THE RV HIGH VOLTAGE PORTION REMAINS IN SERVICE AND THE RA PORT WAS PLUGGED. THE PATIENT'S CHRONIC LEFT VENTRICULAR (LV) LEAD WAS BEING USED AS THE RATE/SENSE LEAD IN THE RV RATE/SENSE PORT OF THE NEW DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310744 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H170

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R 4047| 4517| H170| 4469| 0184