BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL TR

    MDR report key: 1950473 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22529
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NKE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE DAILY IMPEDANCE MEASUREMENTS FOR THE NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) AND NON-BOSTON SCIENTIFIC LEFT VENTRICULAR (LV) LEADS WERE BOTH AROUND 700 OHMS, HOWEVER IN CLINIC THEY EXHIBITED INCREASED IMPEDANCE MEASUREMENTS OF 1900 OHMS. IT WAS NOTED THAT LV THRESHOLD MEASUREMENT HAD BEEN GREATER THAN 4 VOLTS SINCE IMPLANT AND THE RV LEAD THRESHOLD HAD INCREASED FROM 0.4 TO 1.5 VOLTS. THE LEADS WERE BOTH PROGRAMMED BIPOLAR TIP TO RING. FOUR DAYS LATER THE LV LEAD IMPEDANCE MEASUREMENT HAD INCREASED TO GREATER THAN 2300 OHMS AND THE RV LEAD IMPEDANCE MEASUREMENT WAS GREATER THAN 2500 OHMS. IT WAS NOTED THAT IN UNIPOLAR PACING CONFIGURATION THE IMPEDANCE AND THRESHOLD MEASUREMENTS ON BOTH LEADS WERE NORMAL AND STABLE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) NOTED THAT THE NON-BOSTON SCIENTIFIC LV LEAD WAS A UNIPOLAR ONLY LEAD AND INQUIRED HOW THE LEAD WAS ELECTRONICALLY POSITIONED. THE CLINICIAN STATED THAT THE LV LEAD WAS POSITIONED LV TIP TO RV RING. TS SUGGESTED DIFFERENT ELECTRONIC POSITIONING SINCE THE PATIENT IS 99 PERCENT BI-VENTRICULAR PACED. SINCE THE DEVICE IMPLANT WAS RECENT, THERE WAS ALSO CONCERN THAT THE INCREASED IMPEDANCE AND THRESHOLD MEASUREMENTS MAY BE DUE TO A SETSCREW ON THE DEVICE NOT BEING TIGHTENED DOWN. THE CLINICIAN WILL DISCUSS OPTIONS WITH THE PHYSICIAN. NO ADVERSE PATIENT EFFECTS WERE REPORTED AND ALL PRODUCTS REMAIN IMPLANTED. THE INVESTIGATION IS COMPLETE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL TR IMPLANTABLE CHF GENERATOR NKE GUIDANT CRM CLONMEL IRELAND H120

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR 5076| 1888TC| 4193| 8042| H120