BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1954248 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24550
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 17, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE LEAD WAS SURGICALLY ABANDONED DURING THE GENERATOR REPLACEMENT PROCEDURE.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE LEAD REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WOULD BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LEAD SAFETY SWITCH TRIPPED ON THIS RIGHT VENTRICULAR LEAD DUE TO OUT OF RANGE IMPEDANCES GREATER THAN 2,500 OHMS. ISOMETRICS WERE PERFORMED WHICH RECREATED THE ISSUE. THE ARRHYTHMIA LOGBOOK SHOWS SOME EPISODES THAT APPEAR TO BE NOISE. THE SALES REPRESENTATIVE WAS GOING TO DISCUSS THIS FURTHER WITH THE PHYSICIAN REGARDING A LEAD REVISION. NO ADVERSE PATIENT EFFECTS WERE OBSERVED AS THIS PATIENT IS NOT PACEMAKER DEPENDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| L| R 4457| 4480| 1294