BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2944543 · Received February 5, 2013

    Report

    Report Number
    2124215-2013-02531
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT, SUFFERING FROM MENINGITIS AND IN A COMA, WAS GIVEN THIS RIGHT VENTRICULAR (RV) LEAD AND A NON BOSTON SCIENTIFIC DEVICE TO PACE EXTERNALLY, WHILE WAITING FOR THE PATIENT TO RECOVER FROM INFECTION. WHILE THIS LEAD WAS IMPLANTED, THERE WERE INSTANCES OF PAUSES IN PACING FOR GREATER THAN 10 SECONDS OF ASYSTOLE. AS OF TODAY, THERE HAVE BEEN NO NEW IMPLANTS, AND WE BELIEVE THE EXTERNAL PACING SYSTEM IS STILL IN PLACE. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48279 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| L