BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 4903659 · Received July 9, 2015

    Report

    Report Number
    2124215-2015-08840
    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
    PMA / PMN Number
    P960004
    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE DEVICE REPLACEMENT PROCEDURE FOR NORMAL BATTERY DEPLETION, AN INSULATION ISSUE ON THE RIGHT ATRIAL (RA) LEAD WAS CONFIRMED. THE PHYSICIAN ATTEMPTED TO REPLACE THE RA LEAD HOWEVER; 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 RA LEAD WAS RECONNECTED AND ALL MEASUREMENTS WERE FOUND TO BE WITHIN NORMAL LIMITS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445060 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4479

    Patients

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