BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2780136 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12318
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 10, 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 DURING AN IMPLANT PROCEDURE THE PHYSICIAN STATED THAT THIS RIGHT VENTRICULAR (RV) LEAD HAD HIGH PLACEMENT DIFFICULTY AS THE LEAD BECAME STUCK IN THE PATIENT'S VALVE. THE RV LEAD WAS UNABLE TO BE REMOVED FROM THE VALVE AND INADVERTENTLY ABANDONED IN THE PATIENT AND A NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L