BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1874908 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17831
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 7, 2010
    Report Date
    October 5, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED, IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL OBSERVATION NOTED TWISTS IN THE INSULATION AT POINTS 148 AND 485 MILLIMETERS FROM THE TERMINAL PIN. TISSUE WAS NOTED ENTWINED IN THE HELIX MECHANISM. SETSCREW MARKS WERE NOTED ON THE IS-1 TERMINAL PIN; NO SETSCREW MARKS WERE NOTED ON THE IS-1 RING. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. THE LEAD ALSO PASSED THE STYLET INSERTION TEST. ALTHOUGH LABORATORY ANALYSIS COULD NOT CONFIRM THE CLINICAL OBSERVATIONS, THE EXISTENCE OF TWISTS IN THE INSULATION MAY INDICATE THAT TWIDDLING DID OCCUR.

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY, IT WAS REPORTED THE LEAD HAD BEEN EXPLANTED AND REPLACED. A BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED THE PATIENT HAD TWIDDLED THE LEAD LOOSE. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    .

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT ATRIAL LEAD HAD DISLODGED. THE LEAD EXHIBITED HIGH OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS AND EPISODES WITH NOISE; DISLODGEMENT WAS VERIFIED VIA X-RAY. THE NOISE RESULTED IN INAPPROPRIATE ATRIAL TACHYCARDIA RESPONSE MODE SWITCHES. THE PATIENT WAS NOT SYMPTOMATIC. THE PHYSICIAN ELECTED TO PROGRAM OFF THE ASSOCIATED DEVICE'S ATRIAL-BASED FEATURES AND LEAVE THE LEAD IMPLANTED AT THIS TIME.

    Description of Event or Problem · 1

    THE LEAD SUBSEQUENTLY WAS EXPLANTED AND REPLACED WITH NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention N119| 4470| 0184| 4554