BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3930220 · Received July 11, 2014

    Report

    Report Number
    2124215-2014-13722
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    May 27, 2014
    Report Date
    July 21, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    SUBSEQUENT INFORMATION RECEIVED INDICATED THAT THIS RV LEAD WAS FRACTURED AND WAS SURGICALLY ABANDONED. THIS LEAD IS OUT OF SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, OUT-OF-RANGE (OOR) PACING LEAD IMPEDANCE MEASUREMENT GREATER THAN 2000 OHMS AND INTERMITTENT CAPTURE. A LEAD SAFETY SWITCH (LSS) WAS TRIGGERED ON THIS RIGHT VENTRICULAR (RV) LEAD. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE SOURCE OF HIGH OUT-OF-RANGE PACING IMPEDANCE MEASUREMENT WAS NOT CONCLUSIVELY DETERMINED. THIS RV LEAD WAS REPLACED BUT THE FIELD REPRESENTATIVE COULD NOT PROVIDE THE IMPLANT DATE. THIS RV LEAD IS NO LONGER IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405882 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R 1291| 4470| 4471| S606