BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2905447 · Received January 9, 2013

    Report

    Report Number
    2124215-2012-14134
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    October 2, 2012
    Report Date
    June 20, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN WILL CONTINUE TO MONITOR THE LEAD. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL OBSERVATION NOTED THAT THE STYLET WSA RETURNED IN THE LEAD LUMEN, THE CONDUCTOR COILS WERE DEFORMED 175 AND 239 MILLIMETERS (MM) FROM THE TERMINAL PIN, A CUT WAS NOTED IN THE LEAD INSULATION AT 239 MM FROM THE TERMINAL PIN FROM REMOVAL OF THE SUTURE SLEEVE TIE DOWN AND THE HELIX WAS BENT. RESISTANCE TESTING AND A PRESSURE TEST OF THE INNER INSULATION WAS COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED CLINICAL OBSERVATIONS.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT PACING IMPEDANCE MEASUREMENTS FOR THIS RIGHT ATRIAL (RA) LEAD INCREASED FROM THE 350-400 OHM RANGE TO 500 OHMS. IT WAS REPORTED THAT THE LEAD APPEARED LOWER THAN THE RIGHT VENTRICULAR (RV) LEAD ON LATERAL X-RAY IMAGING. AN RA LEAD DISLODGEMENT WAS SUSPECTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT AN INVASIVE PROCEDURE WAS PERFORMED APPROXIMATELY SEVEN MONTHS LATER. UPON OPENING THE POCKET, A SUTURE WAS OBSERVED ON THE LEAD AND ONE ON THE SUTURE SLEEVE. THE LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10589 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR 4136| 4469| K063