BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2911199 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15955
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS LEAD WAS PRESENTED TO THE ER WITH SYMPTOMS OF LIGHTHEADEDNESS. IT WAS UNKNOWN IF THE PACER DEPENDENT PATIENT EXPERIENCED A SYNCOPAL EPISODE. UPON INTERROGATION, INTERMITTENT LOSS OF CAPTURE (LOC) WAS OBSERVED. A LEAD REVISION WAS PERFORMED. THE PHYSICIAN WAS CONCERNED OF THE ANGLE THE LEAD WAS PLACED AT IN THE SEPTUM. THE LEAD WAS REPOSITIONED INTO THE SEPTUM WITH UNACCEPTABLE MEASUREMENTS. ONCE AGAIN, THE LEAD WAS POSITIONED INTO THE TISSUE WITH NO MEASUREMENTS. AT THIS TIME, THE PHYSICIAN ELECTED TO EXPLANT THIS LEAD. UPON LEAD REMOVAL, BODY TISSUE WAS OBSERVED ON THE HELIX OF THE LEAD. THE LEAD WAS THEN DISCARDED AND WOULD NOT BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17652 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R