BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2924957 · Received January 22, 2013

    Report

    Report Number
    2124215-2013-01539
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    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 LEAD HAD DISLODGED RESULTING IN POOR SESNING AND LOSS OF CAPTURE. A SURGICAL INTERVENTION WAS PERFORMED TO EXPLANT AND REPLACE THE LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30865 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4480

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R E110| 4480| 5076| 4136| 0185