BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3210373 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-06992
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 POST IMPLANT, FOLLOW UP REVEALED THIS RIGHT VENTRICULAR LEAD AND DEVICE WERE NOT PACING OR MEASURING R-WAVES, IMPEDANCE OR CHECKING THRESHOLDS. AN ELECTROGRAM WAS PROVIDED TO AN INTERNAL TECHNICAL SERVICE(TS) CONSULTANT FOR THEIR REVIEW. TS REVIEWED THE DATA AND RECOMMENDED VERIFYING THE LEAD POSITION. A REVISION PROCEDURE WAS PERFORMED. UPON REOPENING THE POCKET, THE LEAD PARAMETERS WERE VERIFIED. VISUAL OBSERVATION REVEALED A LEAD CONNECTION. THE LEAD WAS REMOVED AND REINSERTED INTO THE LEAD BARREL AND NORMAL PACING WAS OBSERVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309800 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R