BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1952155 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23356
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 7, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THIS PRODUCT HAS NOT BEEN RETURNED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT THE (B)(4) LABORATORY, THE COMPLETE LEAD WAS RETURNED AND THERE WAS DRIED BLOOD/BODY FLUID NOTED IN THE LEAD LUMEN AND DRIED BODY TISSUE ENTWINED IN THE HELIX. ADDITIONALLY, THERE WAS ELECTRO-CAUTERY DAMAGE AS THERE WAS MELTED INSULATION. ELECTRONICALLY, LEAD WAS FOUND TO BE WITHIN SPECIFICATION. THE CLINICAL OBSERVATION WAS UNABLE TO BE REPRODUCED DURING LABORATORY ANALYSIS.

    Additional Manufacturer Narrative · 1

    ANALYSIS IS CURRENTLY ON-GOING.

    Description of Event or Problem · 1

    THIS PRODUCT WAS RETURNED FOR LABORATORY ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE LEAD HAD DISLODGED. A REVISION PROCEDURE WAS PERFORMED AND THIS PRODUCT WAS EXTRACTED AND REPLACED. NO FURTHER 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 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention H120| 4469| 4592