BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2170264 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-09447
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    May 31, 2011
    Report Date
    July 8, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE EXPLANTED LV LEAD HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. UPON RECEIPT THE LEAD WILL UNDER GO DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A COMPLETE LEAD WAS RETURNED. A VISUAL OBSERVATION WAS PERFORMED ON THE LEAD AND BLOOD WAS NOTED IN THE HELIX HOUSING. THIS LEAD WAS CONFIRMED TO BE FRACTURED AND WORN AT 383 MM FROM THE TERMINAL PIN. MOST LIKELY DUE TO THE SUTURE SLEEVE TIE DOWN. ALSO THE POLY INSULATION SLEEVE WAS BENT UP AND PUCKERED UP FROM 354 AND 383 MM FROM THE TERMINAL PIN. IN ADDITION, CONDUCTOR COILS WERE DEFORMED AND CUTS IN THE POLYURETHANE INSULATION WERE NOTED AT 359 AND 361 MM FORM THE TERMINAL PIN. BASED ON THE ANALYSIS RESULTS, WE SUSPECT THAT FATIGUE OR STRESS IN THE REGION OF THE FRACTURE SITE AND THE SUTURE SLEEVE 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 FAILURES. THE LEAD WAS ARCHIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP VISIT, THIS LEFT VENTRICULAR (LV) LEAD REVEALED HIGH VENTRICULAR PACING IMPEDANCES GREATER THAN 2,000 OHMS. IN ADDITION, A LEAD FRACTURE WAS SUSPECTED ON THE VENTRICULAR LEAD AND HIGH THRESHOLD MEASUREMENTS WAS OBSERVED. A REVISION PROCEDURE WAS PERFORMED, THE LEAD WAS REMOVED, REPLACED AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP VISIT, THIS LEFT VENTRICULAR (LV) LEAD REVEALED HIGH VENTRICULAR PACING IMPEDANCES GREATER THAN 2,000 OHMS. IN ADDITION, A LEAD FRACTURE WAS SUSPECTED ON THE VENTRICULAR LEAD AND HIGH THRESHOLD MEASUREMENTS WAS OBSERVED. A REVISION PROCEDURE WAS PERFORMED, THE LEAD WAS REMOVED, REPLACED AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other| R