BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 6027401 · Received October 13, 2016

    Report

    Report Number
    2124215-2016-16358
    Event Type
    Injury
    Date Received
    October 13, 2016
    Date of Event
    June 1, 2016
    Report Date
    September 2, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    UDI-DI
    00802526265143
    PMA / PMN Number
    P960004/S014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THIS RIGHT ATRIAL (RA) LEAD WAS ALSO DISLODGED AND MIGRATED. ADDITIONAL INFORMATION INDICATES THAT PATIENT WAS A CLASSIC TWIDDLER SYNDROME. CHEST X-RAY CONFIRMED THAT RA LEAD GOT DISLODGED AND BEEN ALL THE WAY UP INSIDE THE POCKET. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PRODUCT WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678168 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4469 00802526265143

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R 4137| 4469| S603