BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2050338 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03425
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 16, 2011
    Report Date
    April 7, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED AT THIS TIME, 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, IT WAS NOTED THAT THE LEAD WAS RETURNED SEVERED AT 122 MM FROM THE TERMINAL PIN WITH THE CONDUCTOR COILS EXTENDING TO 127 MM FROM THE TERMINAL PIN. THE LEAD WAS RETURNED IN TWO SEGMENTS. THE SECOND SEGMENT EXTENDED TO 351 MM FROM THE TERMINAL PIN WITH THE ANODE COIL EXTREMELY STRETCHED AND EXTENDING TO 430 MM. THE CATHODE COIL WAS ALSO FOUND TO BE EXTREMELY STRETCHED AND EXTENDED TO 465 MM. FURTHER ANALYSIS REVEALED THAT THE CONDUCTOR COILS HAVE BOTH BEEN STRETCHED TO THE POINT OF FRACTURE AT THE DISTAL END OF THE DISTAL SEGMENT. THE ANODE COIL WAS EXTREMELY STRETCHED AND APPEARED TO HAVE BEEN PULLED TO THE POINT OF FRACTURE AT 430 MM FROM THE TERMINAL PIN, MOST LIKELY AT THE WELD POINT TO THE ANODE RING. THE CATHODE COIL WAS FOUND TO BE EXTREMELY STRETCHED AND APPEARED TO HAVE BEEN PULLED TO THE POINT OF FRACTURE AT 465 MM FROM THE TERMINAL PIN. VISUAL INSPECTION ALSO SHOWED THAT THE GORE WAS EXTREMELY STRETCHED TO THE POINT OF SEPARATION, AND EXTENDED BEYOND THE CATHODE CONDUCTOR COIL TO 471 MM. THE TIP SEGMENT OF THE LEAD, INCLUDING THE TIP ANODE RING WAS NOT RECEIVED BY THE POST MARKET QUALITY ASSURANCE LABORATORY. ANALYSIS CONFIRMED THE ALLEGATION FROM THE FIELD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT ATRIAL LEAD WAS EXPLANTED DUE TO A FRACTURE. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| L| R 4469| 1851| 1740| 0125| 4440| 0184| A155| E102