BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2910647 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15410
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 9, 2012
    Report Date
    November 13, 2012
    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

    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

    SUBSEQUENT INFORMATION WAS RECEIVED THAT FURTHER TESTING WAS PERFORMED AND NO NOISE, PACING INHABITING OR IMPEDANCE MEASUREMENT VARIATION WAS NOTED. THE OUTPUT WAS REPROGRAMMED TO MAXIMUM IN UNIPOLAR CONFIGURATION AND MINIMUM POCKET STIMULATION WAS OBSERVED. IN BIPOLAR CONFIGURATION, NO POCKET STIMULATION WAS NOTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT PRESENTED TO THE HOSPITAL DUE TO A SYNCOPAL EPISODE. IT WAS SUSPECTED THE SYNCOPE WAS CAUSED BY A HIGH FEVER. AFTER EXAMINING THE SYSTEM, LOSS OF CAPTURE GREATER THAN 3 SECONDS WAS NOTED. ALL DEVICE AND LEAD MEASUREMENTS WERE APPROPRIATE. DURING PROVOCATIVE TESTING, THE SIGNAL WAS CLEAR AND NO NOISE OR LOSS OF CAPTURE WAS OBSERVED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17674 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4459

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L