BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3212935 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09103
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 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 ONE DAY POST IMPLANT, THIS RIGHT VENTRICULAR (RV) LEAD REVEALED AN INCREASE IN PACING THRESHOLS. A RV LEAD DISLODMGNET WAS SUSPECTED AND AN X-RAY MAYBE PERFORMED IN THE NEAR FUTURE. THE LEAD WAS REPROGRAMMED AND THE PATIENT WILL BE FOLLOWED UP AT A LATER DATE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312194 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening