BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2153222 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-07617
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 7, 2011
    Report Date
    May 25, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY, THIS LEAD WAS EXPLANTED. AT THIS TIME, THE LEAD HAS NOT BEEN RETURNED. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT IT WAS NOTED THAT THE LEAD SAFETY SWITCHED WAS TRIGGERED DUE TO HIGH OUT OF RANGE PACING IMPEDANCES ON THE RIGHT VENTRICULAR LEAD. IN ADDITION, IT WAS NOTED THAT THERE WAS NO VENTRICULAR CAPTURE AND IMPEDANCES REMAINED OUT OF RANGE AFTER THE NURSE CHANGED THE CONFIGURATION TO UNIPOLAR. NO ADVERSE PATIENT EFFECTS WERE REPORTED, AND A REVISION WAS PLANNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening| O| R 4457| 1284| 4568| 1292