BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2913346 · Received January 14, 2013

    Report

    Report Number
    2124215-2012-17611
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 12, 2012
    Report Date
    January 28, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED LEAD IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    THE LEAD WAS RETURNED. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE LEAD WAS THOROUGHLY EVALUATED. VISUAL INSPECTION NOTED A CUT IN THE INSULATION AT 16.5 CM FROM THE TERMINAL PIN, WHICH LIKELY OCCURRED DURING REMOVAL OF THE SUTURE SLEEVE, AS THERE WAS A CORRESPONDING CUT ON THE SLEEVE. RESISTANCE TESTING WAS COMPLETED TO ASSESS THE LEAD'S ELECTRICAL PERFORMANCE; MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY 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 SENSING FAILURE AND NOISE. AS THE LEAD WAS ONLY USED FOR SENSING, IT WAS EXPLANTED; A FRACTURE WAS SUSPECTED. THE PATIENT RECEIVED A COMPETITIVE SHOCKING LEAD DURING THE PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    --

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19924 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4474

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R