BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3904376 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-08383
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    October 1, 2013
    Report Date
    July 23, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS THE INFORMATION KNOWN AT THIS TIME. WHEN ADDITIONAL INFORMATON BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL OBSERVATION REVEALED TWO LEAD SEGMENTS SEVERED AT 296 MM FROM THE TERMINAL PIN WERE RETURNED. CUTS WERE NOTED IN THE INSULATION. THE CONDUCTOR COILS WERE STRETCHED AND DEFORMED ON THE TIP SEGMENT. BLOOD AND BODY FLUID WERE NOTED IN THE LEAD LUMEN OF THE TIP SEGMENT. FURTHER DETAILED ANALYSIS REVEALED A FRACTURE AT 296 MM FROM THE TERMINAL PIN. IN ADDITION, THE INSULATION WAS ALSO DAMAGED. THE SUTURE SLEEVE TIE DOWN LOCATION WAS LOCATED AT APPROXIMATELY 233-256 MM FROM THE TERMINAL PIN. DUE TO THE LOCATION AND TYPE OF DAMAGE, IT WAS DETERMINED THE FRACTURE WAS LIKELY DUE TO ENTRAPMENT IN THE CLAVICLE/FIRST-RIB REGION.

    Additional Manufacturer Narrative · 1

    (B)(4). SUBSEQUENTLY, THIS LEAD WAS RECEIVED AT THE POST MARKET QUALITY ASSURANCE LABORATORY. UPON COMPLETION OF THE ANALYSIS, THIS EVENT WILL BE UPDATED.

    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, A REVISION PROCEDURE WAS PERFORMED. LEAD FRACTURE WAS SUSPECTED, HOWEVER THERE WAS NO OBVIOUS LEAD DAMAGE. THIS LEAD WAS REMOVED AND REPLACED. NO RETURN OF THIS LEAD IS INTENDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. NO X-RAY WAS PERFORMED. AS OF THIS DATE, NO REVISION HAS BEEN SCHEDULED. THE DEVICE WAS REPROGRAMMED TO VVI 60.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS ATRIAL LEAD DISPLAYED A HIGH OUT OF RANGE IMPEDANCE MEASUREMENT. DAILY MEASUREMENTS SUGGESTED THE MEASUREMENS HAVE BEEN INCREASED FOR APPROXIMATELY SIX MONTHS. A LEAD FRACTURE WAS SUSPECTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384371 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 4470