BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 4131626 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14398
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 10, 2014
    Report Date
    October 9, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION NOTED THAT THE FINAL SETTING WAS BIPOLAR AND IMPEDANCES REMAINED LOW AND OUT OF RANGE. A REVIEW OF THE ADDITIONAL INFORMATION BY TECHNICAL SERVICES NOTED A POSSIBLE INSULATION ISSUE, ALTHOUGH A ROOT CAUSE WAS NOT DETERMINED DUE TO THE PROVIDED DATA. AN X-RAY WAS ALSO PROVIDED BUT THE PICTURE WAS LOW QUALITY TO SEE THE LOCATION OF THE LEAD. AT THIS TIME THE SYSTEM REMAINS IMPLANTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE DEVICE WAS REPLACED. UPON INSPECTING THE LEADS DURING THE EXPLANT NO ISSUE WAS NOTED. THE LEADS WERE CONNECTED TO A NEW DEVICE. A DEVICE ISSUE WAS SUSPECTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    A DISK ANALYSIS WAS SENT FOR REVIEW TO ENGINEERING WHICH NOTED THAT THE MEMORY OF THE DEVICE HAD NO RESETS OR FAULTS. IT WAS NOTED THAT THE LEADS MAY BE SHORTED RESULTING IN OUT OF RANGE LOW PACING IMPEDANCES. THE LOW PACING IMPEDANCES HAVE AFFECTED DEVICE LONGEVITY. A SYSTEM REVISION WAS DISCUSSED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A NEW IMPLANT PROCEDURE ALL MEASUREMENTS ON THE RIGHT VENTRICULAR LEAD WERE WITHIN NORMAL RANGE WHEN MEASURED WITH A PACING SYSTEM ANALYZER (PSA). AFTER THE PROCEDURE, THE PACING IMPEDANCES WERE LOW OUT OF RANGE ON THE RIGHT VENTRICULAR LEAD. A FOLLOW UP WAS PERFORMED A WEEK LATER WHICH SHOWED THAT THE RIGHT VENTRICULAR PACING IMPEDANCES REMAINED LOW AND OUT OF RANGE, AND LOSS OF CAPTURE WAS SEEN ON THE RIGHT VENTRICULAR LEAD. DURING A THRESHOLDS TEST, THE RIGHT ATRIAL LEAD REVEALED LOSS OF CAPTURE AFTER THE OUTPUTS WERE CHANGED. VARIOUS PROGRAMMING CHANGES WERE MADE WHICH DID NOT RESOLVED THE LOSS OF CAPTURE ON THE RIGHT ATRIAL LEAD. FINALLY THE CONFIGURATION WAS CHANGED TO THE PREVIOUS SETTING AND RIGHT ATRIAL LOSS OF CAPTURE WAS RESOLVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE SYSTEM REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612066 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4480

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R 4457| J176| 4480