BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2173219 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10896
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 15, 2011
    Report Date
    July 28, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT THE POST MARKET QUALITY ASSURANCE LABORATORY VISUAL INSPECTION REVEALED THAT THIS LEAD WAS RETURNED IN TWO SEGMENTS AND HAD BEEN SEVERED 82 MILLIMETERS FROM THE TERMINAL PIN. THERE WERE STRETCHED CONDUCTOR COILS NOTED, WHICH WERE LIKELY ASSOCIATED WITH THE EXPLANT PROCEDURE. ADDITIONALLY, THERE WERE CUTS IN THE POLYURETHANE INSULATION, WHICH WAS MOST LIKELY DUE TO REMOVAL OF THE SUTURE SLEEVE. THE EXTRACTING STYLET WAS RETURNED WITH THE LEAD AS IT WAS STUCK IN THE DISTAL SEGMENT. THE SEGMENTS RETURNED WERE FOUND TO BE ELECTRICALLY CONTINUOUS. THE CLINICAL OBSERVATION WAS UNABLE TO BE REPRODUCED OR CONFIRMED DURING LABORATORY TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD EXHIBITED NOISE WHICH RESULTED IN OVERSENSING AND PACING INHIBITION. THE PACING INHIBITION RESULTED IN GREATER THAN 2 SECONDS OF ASYSTOLE. THE PATIENT UNDERWENT A REVISION PROCEDURE AND THIS LEAD WAS EXPLANTED AND A NEW LEAD WAS SUCCESSFULLY PLACED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    THIS PRODUCT WAS RETURNED FOR LABORATORY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4473

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention 4136| S602| 4472| 1297| 4473