BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3212477 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09226
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 24, 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 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 DURING A ROUTINE FOLLOW-UP TWO WEEKS FOLLOWING ORIGINAL IMPLANT, RIGHT VENTRICULAR (RV) LEAD LOSS OF CAPTURE WAS NOTED DURING VENTRICULAR THRESHOLD TESTING. MAXIMUM VOLTAGE AND 1.0 PULSE WIDTH APPLIED. IT WAS REVEALED THAT THIS PATIENT HAS NODE DISEASE RENDERING THE ATRIAL LEAD TO ALSO BE LIFE-SUSTAINING; HOWEVER, NO ISSUES OCCURRED WITH THE ATRIAL LEAD. THE PHYSICIAN HOSPITALIZED THE PATIENT AND REPOSITIONED THIS RV LEAD SUCCESSFULLY. NO ADDITIONAL ADVERSE EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311996 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R