BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1871894 · Received October 16, 2010

    Report

    Report Number
    2124215-2010-17363
    Event Type
    Injury
    Date Received
    October 16, 2010
    Date of Event
    August 13, 2010
    Report Date
    October 14, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WAS REPORTED AS EXPLANTED AND WILL BE RETURNED FOR ANALYSIS. SHOULD MORE INFORMATION BECOME AVAILABLE TO OUR COMPANY, A FINAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE COMPLETE LEAD WAS RETURNED WITH BOTH THE ANODE AND CATHODE WIRES FRACTURED AT 111 MM WHICH CORRESPONDED TO THE PROXIMAL END OF THE SUTURE SLEEVE. A 119 MM CONSTRICTION IN THE OUTER INSULATION WAS OBSERVED CORRESPONDING TO THE FIRST SUTURE GROOVE WITHIN THE SUTURE SLEEVE. THE OUTER INSULATION WAS WORN AT 111 MM AND AT 134 MM CORRESPONDING TO THE PROXIMAL AND DISTAL ENDS OF THE SUTURE SLEEVE, RESPECTIVELY. 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 CLAVICLE FIRST RIB ZONE 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. WE WILL CONTINUE TO MONITOR FIELD PERFORMANCE TO DETECT AND LEARN FROM SIMILAR EVENTS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS MODEL LEAD SUSTAINED A CONDUCTOR FRACTURE. AS THE CASE WAS REPORTED FROM THE HOSPITAL PERSONNEL TO THE LOCAL SALES REPRESENTATIVE (SR) APPROXIMATELY TWO WEEKS FOLLOWING THE INCIDENT DATE, ADDITIONAL INFORMATION WAS REQUESTED. PRELIMINARY INFORMATION FOR INEFFICIENT STIMULATION WITH IMPEDANCE MEASUREMENTS GREATER THAN 10,000OHMS WERE REPORTED FOR THIS LEAD. THE REMAINING PRODUCTS IN THE SYSTEM WERE UNKNOWN. THE CIRCUMSTANCES SURROUNDING THE LEAD PERFORMANCE TO THE PATIENT ARE UNCLEAR; HOWEVER, THE HOSPITAL REPORTED THAT THE PATIENT SUFFERED FROM ASTHENIA, HEART FAILURE, RENAL FAILURE, AS WELL AS RELATED RISKS TO THESE CONDITIONS, AND/OR POSSIBLE DEATH. THE PHYSICIAN ON CASE REPORTED NO ADVERSE EFFECTS FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4472

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R