BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3040850 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01836
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    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 THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD PRESENTED TO THE EMERGENCY ROOM (ER) IN THE MIDDLE OF THE NIGHT. SIX TO SEVEN SECOND PAUSES WERE OBSERVED WHILE IN THE ER. IT WAS REPORTED THAT THE PATIENT HAD BEEN SEEN IN THE CLINIC THE WEEK PRIOR AND NO ISSUES WERE IDENTIFIED. DEVICE EVALUATION WAS COMPLETED AND AN INTERMITTENT FRACTURE WAS SUSPECTED. THE LEAD IMPEDANCES MEASURED >2000 OHMS AT TIMES, BUT MOST MEASUREMENTS WERE 430 OHMS; LOSS OF CAPTURE WAS ALSO NOTED CAUSING THE LONG PAUSES. THE PATIENT WAS SYMPTOMATIC, BUT WAS NOT SYNCOPAL. SUBSEQUENTLY THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT AND SURGICAL INTERVENTION WAS PERFORMED THE NEXT DAY. THIS RV LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143764 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4473

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| L| R 1280| 4054| 4473| 1291