BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2910214 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15809
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 8, 2012
    Report Date
    August 25, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THE LEAD CONFIRMED IT HAD BEEN SEVERED AND ONLY A 72MM PROXIMAL SEGMENT WAS RETURNED. TESTING OF THE LEAD WAS NOT PERFORMED DUE TO THE LEAD DAMAGE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS RETURNED FOR TESTING NEARLY TWO YEARS FOLLOWING THE INITIAL OBSERVATIONS. THIS PRODUCT ISSUE WILL BE UPDATED WHEN EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF ANY PORTION OF THE LEAD WILL BE AVAILABLE FOR RETURN. 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 A NON BOSTON SCIENTIFIC SYSTEM REPLACEMENT TO A MRI SYSTEM WAS PERFORMED REQUESTED BY THE PATIENT. IT WAS REPORTED THAT DURING THE EXPLANT OF THIS RIGHT ATRIAL (RA) LEAD, A PIECE OF THE ATRIAL MYOCARDIUM WAS ATTACHED WHICH CAUSED THE PATIENT TO EXPERIENCE AN EFFUSION. THE LEAD BEGAN TO SEPARATE WHILE USING A LASER FOR A PORTION OF THE EXTRACTION, AT WHICH TIME THE SUPERIOR VENA CAVA HAD ALSO BECOME EFFUSED. AN OPEN HEART SURGICAL PROCEDURE WAS PERFORMED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS. THE LOCAL FIELD REPRESENTATIVE IS NOT SURE IF ANY PIECES OF THE LEAD WILL BE RETURNED BUT WILL MAKE AN ATTEMPT TO RECOVER WHAT THEY CAN OF THE LEAD PIECES FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17208 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R 4469| MISMATCH| 1290