BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3053326 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04806
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 19, 2013
    Report Date
    April 17, 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

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD REMAINS IMPLANTED. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, NO RETURN OF PRODUCT IS INTENDED. 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 FOUR MONTHS AFTER IMPLANT, DURING A FOLLOW-UP VISIT, THIS RIGHT VENTRICULAR LEAD DISPLAYED LOSS OF CAPTURE AND UNDERSENSING. AN X-RAY REVEALED THE LEAD WAS DISLODGED. IN ADDITION, THERE WAS A WALL PERFORATION AT THE SEPTUM-APICAL LEVEL AND THE LEAD TIP HAD MIGRATED TOWARDS THE PLEURAL CAVITY. THE PATIENT WITH THIS LEAD IS ASYMPTOMATIC. A LEAD REVISION IS INTENDED IN THE NEAR FUTURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. SUBSEQUENTLY A REVISION PROCEDURE WAS PERFORMED. THIS LEAD WAS REMOVED, REPLACED AND DISCARDED BY THE FACILITY. NO FURTHER ADVERSE PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156208 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R