BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1771341 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12386
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 8, 2010
    Report Date
    January 13, 2011
    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

    TECHNICAL SERVICES REFERRED THE CALLER TO THE PATIENT'S PHYSICIAN. THERE IS NO FURTHER INFORMATION AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WOULD BE UPDATED.

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT A LEAD SAFETY SWITCH TRIGGERED ON THIS RIGHT VENTRICULAR (RV) LEAD. DAILY MEASUREMENTS VARY FROM 300-2000 OHMS. THE IMPEDANCE IN BIPOLAR AFTER BEING RESET IS GREATER THAN 2500 OHMS. IN UNIPOLAR IMPEDANCES ARE APPROXIMATELY 500 OHMS. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS AS A RESULT OF THIS.

    Description of Event or Problem · 1

    SEVEN MONTHS LATER THIS LEAD WAS SURGICALLY ABANDONED DUE TO THE EXISTING IMPEDANCES PROBLEMS OVER THE PAST YEAR. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 83 YR Life Threatening 4457| 4470| 1280| S603