BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3212518 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08332
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    October 16, 2006
    Report Date
    May 16, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    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 FOLLOWING THE IMPLANT OF THIS RIGHT VENTRICULAR (RV) LEAD, IT WAS DISCOVERED THAT THE LEAD HAD DISLODGED. A REVISION WAS PERFORMED ON THE SAME DAY AND THE LEAD WAS SUCCESSFULLY REPOSITIONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. OVER SIX YEARS LATER, IT WAS REPORTED THAT THIS PATIENT PASSED AWAY. THERE WERE NO ALLEGATIONS AGAINST THE IMPLANTED RV LEAD OR THAT IT CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. THE LEAD IS NOT EXPECTED TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312215 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R 1194| 4457