BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3050150 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-03903
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 22, 2013
    Report Date
    March 4, 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 OF TODAY, THE LEAD REMAINS IN SERVICE PENDING A REPOSITIONING PROCEDURE. THIS REPORT WILL BE UPDATED WHEN ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE LEAD REVISION WAS PERFORMED. THIS RV LEAD WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE EXPLANTED LEAD WAS NOT EXPECTED TO BE RETURNED. 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 VENTRICULAR (RV) LEAD EXHIBITED IN INCREASE IN PACING THRESHOLD MEASUREMENTS, FROM 0.5V AT 0.4MS TO 2.1V AT 0.4MS. AN X-RAY WAS PERFORMED AND CONFIRMED THE LEAD HAD DISLODGED. THE EXCESS LEAD THAT HAD BEEN LOOPED NEAR THE DEVICE HAD MIGRATED TO THE DISTAL END. NO ADVERSE PATIENT EFFECTS WERE REPORTED. A LEAD REVISION WAS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149567 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R