BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3232675 · Received July 18, 2013

    Report

    Report Number
    2124215-2013-11412
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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 THIS RIGHT ATRIAL (RA) LEAD EXHIBITED LOSS OF CAPTURE (LOC) AT MAXIMUM OUTPUT. IT WAS REPORTED THAT THE RA LEAD APPEARED TO BE DISLODGED A DAY POST IMPLANT. A REVISION PROCEDURE WAS DONE IN WHICH THIS RA LEAD WAS REPOSITIONED. THIS RA LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334525 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R 4592| MISMATCH| N140| 4469| 0295