BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 4903647 · Received July 9, 2015

    Report

    Report Number
    2124215-2015-08841
    Event Type
    Injury
    Date Received
    July 9, 2015
    Date of Event
    June 20, 2015
    Report Date
    June 23, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS INDICATED THE LEAD WOULD NOT BE RETURNED. 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 ONE DAY FOLLOWING THE IMPLANT PROCEDURE, THE THRESHOLD MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) LEAD HAD INCREASED. AFTER REVIEWING THE X-RAY, IT APPEARED THE RV LEAD HAD DISLODGED. AS A RESULT, A REVISION PROCEDURE WAS SCHEDULED. DURING THE REVISION PROCEDURE, IT WAS NOTED THE ACTIVE FIXATION HELIX WAS NOT SUITABLE FOR THE STATE OF THE PATIENT'S CARDIAC MUSCLE AND THE LEAD COULD HAVE DISLODGED FOR ANATOMICAL REASONS. A NEW TINED RV LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445736 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R (B)(4)| (B)(4)| (B)(4)