BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3043281 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-01877
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 24, 2013
    Report Date
    February 12, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    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.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP APPOINTMENT, LOSS OF CAPTURE WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. UPON FURTHER INVESTIGATION, DAILY MEASUREMENTS REVEALED IMPEDANCE MEASUREMENTS GREATER THAN 2500 OHMS. AS A FRACTURE WAS SUSPECTED, A LEAD REVISION PROCEDURE WAS SCHEDULED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION WAS RECEIVED THAT THE LEAD WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145326 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4458

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Hospitalization| L 4458| 0482