BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 4903646 · Received July 9, 2015

    Report

    Report Number
    2124215-2015-08839
    Event Type
    Injury
    Date Received
    July 9, 2015
    Date of Event
    June 11, 2015
    Report Date
    July 10, 2015
    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.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ON-GOING. THIS REPORT WILL BE UPDATED UPON RECEIPT OF ADDITIONAL DETAILS.

    Description of Event or Problem · 1

    SUBSEQUENTLY, THIS PATIENT UNDERWENT A REVISION PROCEDURE AND THIS PRODUCT WAS EXPLANTED AND REPLACED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE DEVICE REPLACEMENT PROCEDURE FOR NORMAL BATTERY DEPLETION, AN INSULATION ISSUE ON THE RIGHT VENTRICULAR (RV) LEAD WAS CONFIRMED. DUE TO THE PATIENT BEING 100% RV PACE DEPENDENT, THE PHYSICIAN ATTEMPTED TO REPLACE THE RV LEAD. HOWEVER; WHEN ATTEMPTING TO IMPLANT THE RV LEAD, THE SHEATH COULD NOT BE INSERTED DUE TO OBSTRUCTION OF THE SUBCLAVIAN VEIN. THE DECISION WAS DECIDED TO IMPLANT A NEW LEAD AT A LATER DATE. THE CHRONIC RV LEAD WAS RECONNECTED AND ALL MEASUREMENTS WERE FOUND TO BE WITHIN NORMAL LIMITS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444953 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4456

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| L| R 4456| 0639| 1283| 4479| 4250