BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2041067 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01355
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO ADDITIONAL INFORMATION CONCERNING THIS REPORT IS EXPECTED AT THIS TIME, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL LEAD WAS CAPPED AND SURGICALLY ABANDONED DUE TO A HIGH OUT-OF-RANGE (OOR) PACE IMPEDANCE MEASUREMENT OBSERVED DURING NORMAL REPLACEMENT OF THE ASSOCIATED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). A BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED THE LEAD HAD EXHIBITED OCCASIONAL HIGH IMPEDANCE MEASUREMENTS AS RECORDED IN THE ICD MEMORY AND WHEN MEASURED WITH A PACING SYSTEM ANALYZER (PSA) DURING THE REPLACEMENT PROCEDURE. WHEN THE LEAD WAS CONNECTED TO THE REPLACEMENT DEVICE, THE HIGH OOR MEASUREMENT WAS OBSERVED DURING DEVICE INTERROGATION. IT WAS SPECULATED THAT THE LEAD HAD A MICRO-FRACTURE CLOSE TO THE RING ELECTRODE THAT WAS AGGRAVATED BY THE DEVICE CHANGEOUT PROCEDURE. ANOTHER LEAD WAS IMPLANTED WITH NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4472

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention 4472| 0154| T125