BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 4132353 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14756
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    March 7, 2014
    Report Date
    July 22, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 IMPLANTED WITH THIS RIGHT VENTRICULAR (RV) LEAD, AND ANOTHER MANUFACTURER'S DEVICE, PRESENTED TO THE EMERGENCY ROOM WITH PRE-SYNCOPE SYMPTOMS. INTERROGATION OF THE DEVICE FOUND RV LOSS OF CAPTURE. IT WAS REPORTED THE PATIENT'S SYMPTOMS CORRESPONDED TO AN INCREASE IN THRESHOLD MEASUREMENTS. THE LEAD WAS IMAGED AND THERE WAS NO SIGN OF A LEAD FRACTURE. AN INVASIVE PROCEDURE WAS PERFORMED. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED WITH ANOTHER MANUFACTURER'S LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612953 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R 4471| 1298| 4470