BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3040660 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01097
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 4, 2013
    Report Date
    March 6, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

    ADDITIONAL INFORMATION BECAME AVAILABLE THAT THIS LEAD WAS SUCCESSFULLY REVISED AND REMAINS IN SERVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE (LOC) INTERMITTENTLY WHEN THE PATIENT INHALES DEEPLY, AS WELL AS INCREASED THRESHOLDS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND SUGGESTED IT MIGHT POSSIBLY BE A MICRODISLODGEMENT OF THE LEAD, AND SHOULD CONSIDER A CHEST X-RAY TO DETERMINE LEAD POSITION. SINCE THE PATIENT IS NOT DEPENDANT ON PACING, THE DECISION WAS MADE TO SEE THE PATIENT IN A FEW WEEKS AND DETERMINE A COURSE OF ACTION AT THAT TIME. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143618 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4456

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R 1186| 292-03| 4456| S601| 430-07