BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3043334 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02176
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    December 12, 2012
    Report Date
    February 5, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. RESISTANCE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT LOSS OF CAPTURE AT MAXIMUM OUTPUTS, AN INCREASE IN PACING IMPEDANCES, UNDERSENSING, AS WELL AS SOME OVERSENSING. SURGICAL INTERVENTION WAS PERFORMED AND UNDER FLUOROSCOPIC EVALUATION THE LEAD WAS OBSERVED TO BE DISLODGED AND HANGING LOOSELY IN THE SUPERIOR VENA CAVA. THE LEAD WAS SUCCESSFULLY EXPLANTED AND A NEW RA LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146264 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R 4469| 4136| K173