BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 711235 · Received May 9, 2006

    Report

    Report Number
    2124215-2006-13080
    Event Type
    Malfunction
    Date Received
    May 9, 2006
    Date of Event
    January 6, 2006
    Report Date
    January 6, 2006
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT A CLINICIAN REPORTED THAT WHILE PERFORMING UNSPECIFIED TESTING, LOSS OF VENTRICULAR CAPTURE WAS OBSERVED. HOWEVER, WHEN THIS VENTRICULAR LEAD WAS THOROUGHLY EVALUATED, NO LEAD ABNORMALITIES WERE DETECTED. A REVIEW OF THE DEVICE ELECTROGRAMS AND COUNTERS REVEALED NO ABNORMALITIES. WHILE TESTING THE PATIENT'S ATRIAL LEAD, IMPEDANCE MEASUREMENTS RANGED BETWEEN 590-1900 OHMS AND SEVERAL MEASUREMENTS DURING THE FOLLOW-UP TESTING WERE GREATER THAN 2500 OHMS. NOISE WAS OBSERVED ON THE ATRIAL LEAD WITH ISOMETRICS, AS WELL AS NO CAPTURE. IT WAS REPORTED THE PATIENT HAD A HICKMAN CATHETER PLACED DIRECTLY ON TOP OF THE PATIENT'S PACEMAKER. NO ADVERSE PATIENT EFFECTS OR SYMTOMS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4477 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other