BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2042462 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01748
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    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 AS THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE ASSOCIATED CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D) INHIBITED RIGHT VENTRICULAR (RV) PACING DURING A ROUTINE IMPLANT PROCEDURE. THE RV LEAD HAD BEEN IMPLANTED AND WAS PACING SUFFICIENTLY. THE LEFT VENTRICULAR (LV) LEAD WAS THEN IMPLANTED AND CONNECTED TO THE DEVICE, AT WHICH POINT, THE RV LEAD CEASED PACING. THE LOCAL FIELD REPRESENTATIVE (FR) INDICATED THAT THE RV LEAD WAS DISCONNECTED, THE TERMINAL PINS WERE CLEANED AND THEN RE-INSERTED. THE DEVICE AND LEAD THEN BEGAN PACING AS DESIRED. THERE WERE NO ADVERSE PATIENT EFFECTS. THE SYSTEM REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H177

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Life Threatening 1283| N119| 430-10| 4543| (B)(4)| MISMATCH| H177| 0158| 4472