BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3211476 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08251
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 14, 2013
    Report Date
    June 10, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION DID NOT IDENTIFY ANY LEAD ANOMALIES. RESISTANCE AND PRESSURE TESTS WERE PERFORMED WHICH CONFIRM THE ELECTRICAL CONTINUITY AND INSULATION INTEGRITY OF THE LEAD. ANALYSIS WAS UNABLE TO CONFIRM ANY LEAD ISSUES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE LEAD IS BEING EVALUATED IN OUR POST MARKET QUALITY ASSURANCE LABORATORY. THIS PRODUCT ISSUE WILL BE UPDATED WHEN EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD BEEN TRANSPORTED TO THE HOSPITAL DUE TO A MYOCARDIAL INFARCTION (MI) AND WAS BRADYCARDIC. LOSS OF CAPTURE AND PACING INHIBITION WAS NOTED AND THE PHYSICIAN STATED HE WAS NOT CERTAIN IF THE MI OCCURRED PRIOR TO THE CLINICAL OBSERVATIONS. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS REMOVED FROM SERVICE AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309539 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L 4457| 4470| S603| 4137