BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2910036 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16245
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 6, 2012
    Report Date
    November 6, 2012
    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 SHORTLY AFTER IMPLANT THIS RIGHT ATRIAL LEAD DISPLAYED HIGH PACING THRESHOLDS ALONG WITH UNDERSENSING DUE TO A SUSPECTED DISLODGEMENT. THE LEAD WAS REPROGRAMMED TO HIGHER OUTPUTS AND CHEST X-RAY WAS SCHEDULED FOR THE NEAR FUTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18783 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4480

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R