BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3081039 · Received April 26, 2013

    Report

    Report Number
    2124215-2013-06822
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    March 6, 2013
    Report Date
    July 3, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE LEAD WAS ANALYZED AND INSPECTED. THE COMPLETE LEAD WAS RETURNED WITH SET SCREW MARKS NOTED ON THE TERMINAL PORTION. ALSO, THE HELIX WAS SLIGHTLY BENT AND TISSUE WAS NOTED ENTWINED IN THE HELIX.

    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

    ADDITIONAL INFORMATION WAS OBTAINED INDICATING THAT DEPENDING ON WHEN THE HELIX WAS DAMAGE, THE BENT HELIX MAY HAVE CONTRIBUTED TO THE DISLODGEMENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE BRADY LEAD WAS DISLODGED SEVERAL TIMES DUE TO PATIENT CONDITION. THE PHYSICIAN IMPLANTED ANOTHER LEAD SUCCESSFULLY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE FIELD REPRESENTATIVE WERE UNSUCCESSFUL. OUR RECORDS INDICATE THAT THE LEAD WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182876 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Hospitalization| L| R K173| 4136| 4469