BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3210161 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07491
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE LEAD CANNOT BE RETURNED FOR ANALYSIS, THE CLINICAL OBSERVATIONS CANNOT BE CONFIRMED. 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 IMPLANTED WITH THIS RIGHT VENTRICULAR (RV) LEAD EXPERIENCED CARDIAC ARREST FOR LONGER THAN TWO SECONDS. DURING THE DEVICE CHECK, THE RV PACING IMPEDANCE MEASUREMENTS WERE GREATER THAN 2,500 OHMS AND A LEAD FRACTURE WAS SUSPECTED. IT WAS NOTED THAT AT THE PREVIOUS DEVICE CHECK IN (B)(6) 2012, NO LEAD PROBLEMS WERE OBSERVED. A REVISION PROCEDURE WAS PERFORMED AND THIS LEAD WAS SURGICALLY ABANDONED. A NEW RV LEAD WAS IMPLANTED; THE DEVICE WAS ALSO REPLACED DURING THE PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310882 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R