BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 3212529 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08153
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 15, 2013
    Report Date
    October 8, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE TERMINAL PORTIONS OF THE RA AND RV LEADS WERE RETURNED WITH THE DEVICE. ANALYSIS CONFIRMED THAT BOTH LEADS WERE STUCK IN THE DEVICE HEADER.

    Additional Manufacturer Narrative · 1

    THE LEADS ARE NOT EXPECTED TO 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

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN ELECTIVE REPLACEMENT PROCEDURE, THE IS-1 RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) SETSCREWS OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WERE UNABLE TO BE DISENGAGED. DIFFERENT WRENCHES WERE USED AND THE DEVICE HEADER WAS REMOVED, BUT THE SETSCREWS REMAINED STUCK IN PLACE. AS A RESULT, THE RV AND RA LEADS HAD TO BE CUT AND THE PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL WHERE THEY ARE CURRENTLY WAITING TO HAVE THE LEAD EXTRACTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED; HOWEVER THE PATIENT WILL REMAIN HOSPITALIZED UNTIL THE LEADS ARE EXTRACTED AND A NEW SYSTEM IS IMPLANTED. THE CRT-D WILL BE RETURNED FOR IMMEDIATE LABORATORY ANALYSIS.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313117 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4480

    Patients

    Seq Age Sex Outcome Treatment
    1