BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3211043 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07820
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 30, 2013
    Report Date
    June 10, 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

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. 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.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, THIS ATRIAL AND RIGHT VENTRICULAR LEADS WERE IMPLANTED AND LEAD TESTING APPEARED ACCEPTABLE. PRIOR TO FIXATION, LEAD TESTING WAS PERFORMED REVEALING NO CAPTURE AT HIGH OUTPUT SETTINGS. ATTEMPTS WERE MADE TO REPOSITION REVEALED SIMILAR RESULTS. DURING A FURTHER REPOSITIONING ATTEMPT THE PATIENT'S BLOOD PRESSURE DROPPED AND OXYGEN SATURATION DECREASED. AN ECHOCARDIOGRAM REVEALED A VENTRICULAR PERFORATION. PERIOCARDIOCENTESIS WAS PERFORMED. DUE TO THE PATIENT'S WORSENING CONDITION, A DECISION WAS MADE TO REMOVE THE LEADS AND PERFORM A FOLLOW UP INTERVENTION WHEN THE PATIENT'S CONDITION STABILIZED. THIS LEAD WAS REMOVED AND RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310963 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R