BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THINLINE II STEROX

    MDR report key: 2173147 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10746
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 6, 2011
    Report Date
    September 12, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN REQUESTED FOR THE X-RAY TO BE REVIEWED. THIS LEAD IS NOT EXPECTED TO BE RETURNED FOR LABORATORY ANALYSIS. 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 OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS LEAD WAS CONFIRMED TO BE FRACTURED APPROXIMATELY 208-209 MILLIMETERS FROM THE LEAD'S 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.

    Description of Event or Problem · 1

    AT A A LATER DATE, THE LEAD WAS RETURNED FOR LABORATORY ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A NORMAL PATIENT FOLLOW UP, THE PACING IMPEDANCE MEASUREMENT ON THIS TRANSVENOUS IMPLANTABLE LEAD WAS ABOVE 3,000 OHMS AND THERE WAS LOSS OF CAPTURE AT THE HIGHEST PROGRAMMED PACING OUTPUTS FROM THE ASSOCIATED DEVICE. THE LEAD CONFIGURATION WAS CHANGED TO UNIPOLAR MODE AND THE MEASUREMENTS WERE WITHIN NORMAL RANGE. A LEAD REVISION WAS PERFORMED AND DIFFICULTIES WERE ENCOUNTERED WHEN EXPLANTING THE LEAD. THE LEAD BECAME STUCK AT THE COSTOCLAVICULAR LIGAMENT AND EVENTUALLY HAD TO BE CUT, CAPPED AND ABANDONED IN THE PATIENT. A CHEST X-RAY WAS PERFORMED AND IT APPEARED THAT THIS LEAD HAD FRACTURED AROUND THE SUTURE SLEEVE. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THINLINE II STEROX IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4372

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention