BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 4131479 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14932
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 1, 2014
    Report Date
    March 9, 2018
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT WILL BE UPDATED UPON RECEIVED OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY A THOROUGH PRODUCT ANALYSIS WAS PERFORMED. VISUAL INSPECTION REVEALED THE SILICONE INSULATION WAS DAMAGED AND ALL THE CONDUCTOR COILS WERE FRACTURED APPROXIMATELY 34 CM FROM TERMINAL PIN. DUE TO THE LOCATION AND TYPE OF DAMAGE IT IS LIKELY THIS WAS CAUSED BY ENTRAPMENT IN THE CLAVICLE/ FIRST-RIB REGION. AS A RESULT, THE CLINICAL OBSERVATIONS WERE CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS CURRENTLY UNDERGOING ANALYSIS. THIS REPORT WILL BE UPDATED UPON ITS COMPLETION.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE REMOTE PATIENT MONITORING SYSTEM TRIGGERED AN ALERT FOR HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS INCREASING FROM 300 TO GREATER THAN 2,000 OHMS IN ADDITION TO NOISE AND OUT OF RANGE INTRINSIC AMPLITUDE MEASUREMENTS FOR THIS RIGHT ATRIAL (RA) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PATIENT WAS REPORTED AS NOT PACEMAKER DEPENDENT. THE ICD WAS REPROGRAMMED TO VVI-50 WHILE THE PATIENT AWAITS THEIR REVISION PROCEDURE TO BE SCHEDULED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SYSTEM REMAINS IN SERVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THIS PATIENT UNDERWENT A REVISION PROCEDURE FOR AN UNRELATED REASON DURING WHICH THE PREVIOUSLY ABANDONED PORTION OF THIS LEAD WAS REMOVED. A NEW DEVICE AND LEADS WERE SUBSEQUENTLY IMPLANTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING FURTHER EVALUATION OF THE LEAD WAS PERFORMED AND FRACTURE WAS SUSPECTED. FURTHER, PART OF THE LEAD WAS NOTED TO BE IN THE PATIENT'S RIGHT VENTRICLE WHICH IS SUSPECTED TO HAVE RESULTED IN INCREASED EPISODES OF ARRHYTHMIA. A REVISION PROCEDURE WAS PERFORMED WHEREIN PORTIONS OF THIS LEAD WERE EXPLANTED, HOWEVER, THE PHYSICIAN WAS UNABLE TO EXTRACT THE PORTION LOCATED IN THE VENTRICLE. A NEW ATRIAL LEAD WAS THEN IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. PORTIONS OF THE LEAD ARE EXPECTED FOR RETURN AND ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610454 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4474

    Patients

    Seq Age Sex Outcome Treatment
    1 0696| F142| 4474