BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3921768 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-11007
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 28, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS LEAD WAS THOROUGHLY INSPECTED AND ANALYZED. DAMAGE TO THE LEAD WAS NOTED. DUE TO THE LOCATION AND MORPHOLOGY OF DAMAGE TO THE LEAD IT IS LIKELY THAT EXTERNAL STRESS APPLIED TO THE LEAD BODY RESULTED IN THE CLINICAL OBSERVATIONS. PAST EXPERIENCE SUGGESTS PATIENT MANIPULATION OF THE LEAD THROUGH THE SKIN IS A CONTRIBUTING FACTOR TO DAMAGE OF THIS TYPE. TWIDDLER¿S SYNDROME CAN LEAD TO DISLODGEMENT AND COMPLICATIONS RELATED TO DISLODGEMENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A PATIENT TWIDDLED THE DEVICE AND HAD THE RIGHT ATRIAL (RA) LEAD PULLED OUT. FURTHER, NO CAPTURE AND SENSING WAS NOTED. WHEN THE PATIENT WAS CHECKED IN THE OFFICE, AN X-RAY WAS PERFORMED AND FOUND RA LEAD IN THE SUPERIOR VENA CAVA. THE RA LEAD WAS EXPLANTED AND WAS RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400141 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R 4470| E142| 0296