BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3761248 · Received April 21, 2014

    Report

    Report Number
    2124215-2014-05792
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    March 4, 2014
    Report Date
    September 18, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4); THE RETURN OF THE PRODUCT WAS REQUESTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEAD CAME OUT IN PIECES DURING EXPLANT AND WILL NOT BE RETURNED. 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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH OUT-OF-RANGE PACING LEAD IMPEDANCE MEASUREMENT GREATER THAN 2000 OHMS. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE LEAD WAS TESTED WITH PACING SYSTEM ANALYZER (PSA) AND HIGH OUT-OF-RANGE IMPEDANCE MEASUREMENT WAS ALSO OBSERVED. THE LEAD WAS ABANDONED SURGICALLY AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEAD WAS LATER EXPLANTED DURING REPLACEMENT OF THE RIGHT VENTRICULAR (RV) LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240629 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| L| R 4555| H210| 6986| N161| 4135| 4538| 4469