BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2789400 · Received October 15, 2012

    Report

    Report Number
    2124215-2012-13921
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    September 25, 2012
    Report Date
    April 25, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL OBSERVATION REVEALED DRIED BODY FLUID IN THE LEAD LUMEN. THE CONDUCTOR COILS WERE DEFORMED 232, 258, AND 290 MILLIMETERS (MM) FROM THE TERMINAL PIN. CUTS IN THE INSULATION WERE FOUND 318 TO 320 MM AND 335 TO 339 MM FROM THE TERMINAL PIN. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AS VISUAL INSPECTION DID NOT REVEAL ANYTHING WRONG WITH THE LEAD THAT WOULD CAUSE THE DISLODGMENT.

    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 (RA) LEAD HAD DISLODGED ONE DAY POST IMPLANT. A REVISION PROCEDURE WAS PERFORMED TO REPOSITION THE LEAD; HOWEVER, UNSUCCESSFUL. THE LEAD WAS EXPLANTED. ANOTHER LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R S606| 4469| 4470| 4137| 4136