BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2173186 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10388
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 16, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS RV LEAD WILL NOT BE RETURNED TO BOSTON SCIENTIFIC DUE TO BEING SURGICALLY ABANDONED. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO COLLAPSING. A REVIEW OF AN ELECTROCARDIOGRAM DISPLAYED INTERMITTENT LOSS OF CAPTURE (LOC). THIS PATIENT HAD AN UNDERLYING RHYTHM OF 50 BEATS/MINUTE. DEVICE INTERROGATION REVEALED A YELLOW ALERT DUE TO MODE SWITCHING. THE SAFETY SWITCH HAD BEEN TRIGGERED DUE TO HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS. THE LEAD SWITCHED FROM BIPOLAR TO UNIPOLAR. THE PHYSICIAN SUSPECTS RIGHT VENTRICULAR (RV) LEAD FRACTURE AND/OR INSULATION DAMAGE. THE DECISION WAS MADE TO REPROGRAM THE MAXIMUM OUTPUTS UNTIL LEAD REPLACEMENT CAN TAKE PLACE. SUBSEQUENTLY, ADDITIONAL INFORMATION WAS RECEIVED THAT THIS RV LEAD WAS SURGICALLY ABANDONED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR 1198| 4457