BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3052761 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05424
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 1, 2012
    Report Date
    October 8, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE LEAD REMAINS IMPLANTED. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS LEAD WAS CONFIRMED TO BE FRACTURED NEAR THE DISTAL END OF THE SUTURE SLEEVE TIE DOWN AREA. BASED ON THE ANALYSIS RESULTS, WE SUSPECT THAT FATIGUE OR STRESS IN THE REGION OF THE FRACTURE SITE DUE TO RELATIVE MOTION BETWEEN THE SUTURE SLEEVE AND AN ANATOMICAL FEATURE LED TO THE FRACTURE. AS A LEAD MOVES IN RESPONSE TO NORMAL HEART RHYTHMS AND BLOOD FLOW, EXTENSIVE FLEXING OVER A PERIOD OF TIME MAY CAUSE FATIGUE OR STRESS, WEAKENING THE COIL, ULTIMATELY RESULTING IN A FRACTURE. THIS CAN OCCUR BETWEEN THE SUTURE SLEEVE AND SOME OTHER PART OF THE ANATOMY. FATIGUE FRACTURES IN THE POCKET OR CLAVICULAR/FIRST RIB AREA ARE WELL KNOWN AND DOCUMENTED IN THE INDUSTRY. A COMBINATION OF LEAD DESIGN, IMPLANT TECHNIQUES, AND PATIENT ANATOMY AND ACTIVITY LEVEL CONTRIBUTE TO THESE TYPES OF OCCURRENCES.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED ONCE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD HAD DISPLAYED OUT OF RANGE IMPEDANCE MEASUREMENTS, NO SENSING AND A LOSS OF CAPTURE (LOC) AT MAXIMUM OUTPUTS. IT WAS LATER DETERMINED THE LEAD WAS FRACTURED. THE LEAD REVISION WAS RESCHEDULED DUE TO OCCLUSION. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS LEAD HAS BEEN EXPLANTED WITH AND WILL BE RETURNED FOR ANALYSIS. A NEW LEAD WAS IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154900 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4473

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening| R 4473| T165| 0185