BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3904913 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09449
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 21, 2014
    Report Date
    September 25, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE ANALYSIS, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL OBSERVATION REVEALED DRIED BODY TISSUE ENTWINED THROUGHOUT THE HELIX MECHANISM. CUTS IN THE INSULATION WERE NOTED AT 288-291 MM DUE TO THE REMOVAL OF THE SUTURE SLEEVE TIE DONE. ANALYSIS DID NOT DETERMINE ANY MANUFACTURING ISSUE THAT WOULD HAVE LED TO THE LEAD DISLODGEMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    SUBSEQUENTLY, THIS LEAD WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    - -

    Description of Event or Problem · 1

    - -

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS RIGHT VENTRICULAR LEAD DISPLAYED INCREASED THRESHOLD MEASUREMENTS. IN ADDITION, THE IMPEDANCE MEASUREMENTS HAVE DECREASED SLIGHTLY. AMPLITUDE MEASUREMENTS HAVE DECREASED. PACING INHIBITION WAS OBSERVED. LEAD DISLODGEMENT WAS SUSPECTED. THE OUTPUT SETTINGS WERE REPROGRAMMED AND A REVISION PROCEDURE IS INTENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED, HOWEVER THE PATIENT WAS HOSPITALIZED. A REVISION PROCEDURE WAS PERFORMED. LEAD DISLODGMENT WAS NOT OBSERVED ON THE X-RAY OR BY VISUAL INSPECTION. ATTEMPTS TO REPOSITION THE LEAD WERE UNSUCCESSFUL, HOWEVER THE LEAD COULD NOT BE AFFIXED PROPERLY. A DECISION WAS MADE TO REPLACE THE LEAD. IT WAS THOUGHT THE LEAD POSITION MAY HAVE CAUSED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384194 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 4471| J175