BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2780415 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12567
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 14, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS INDICATED THIS LEAD WOULD 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 DURING THE IMPLANT PROCEDURE, THE LEAD WAS UNPACKED AND WAS FOUND TO BE BENT. HOWEVER, THE LEAD WAS ATTEMPTED TO BE IMPLANTED AND WHEN IT WAS ENGAGED, MANIPULATION BECAME WORSE. WHEN THE LEAD WAS REMOVED, IT WAS ALMOST COMPLETELY SEVERED. WHEN THE STYLET WAS INSERTED, THE LEAD SEVERED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1