BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 3210039 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07242
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 18, 2013
    Report Date
    November 27, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. THE PROXIMAL ONLY SEGMENT OF THE LEAD WAS RETURNED SEVERED 24.5 CENTIMETERS (CM) FROM THE TERMINAL PIN. VISUAL OBSERVATION NOTED THE PRESENCE OF SET SCREW MARKS ON THE LEAD TERMINAL PIN AND RING. RESISTANCE TESTING WAS COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY ANALYSIS COULD NOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS BASED ON THE RETURNED PORTION OF THE LEAD.

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN WILL CONTINUE MONITORING. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    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

    ADDITIONAL INFORMATION WAS RECEIVED THAT AN RA LEAD REVISION PROCEDURE WAS PLANNED. PRIOR TO THE PROCEDURE, FLUOROSCOPIC IMAGING REVEALED THAT THE RA AND RIGHT VENTRICULAR (RV) LEADS WERE FRACTURED. AN INVASIVE PROCEDURE WAS PERFORMED. THE LEADS WERE SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT DURING A ROUTINE IN-CLINIC FOLLOW UP THREE MONTHS LATER, THIS RA LEAD EXHIBITED OVERSENSING RESULTING IN INAPPROPRIATE ATRIAL TACHY RESPONSE (ATR) MODE SWITCHES AND HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,500 OHMS. IT WAS NOTED THAT THE PATIENT LOST A SIGNIFICANT AMOUNT OF WEIGHT AND FELT THAT THE LEAD MOVED AROUND MORE IN THE POCKET. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE IN-CLINIC FOLLOW UP, THE LEAD SAFETY SWITCH (LSS) FEATURE WAS OBSERVED TO HAVE BEEN ACTIVATED ON THIS RIGHT ATRIAL (RA) LEAD. IT WAS UNABLE TO BE DETERMINED WHEN THE LSS FEATURE WAS ACTIVATED. REVIEW OF DEVICE MEMORY REVEALED THAT PACING IMPEDANCE MEASUREMENTS IN DAILY MEASUREMENTS HAD BEEN 410 TO 430 OHMS, HOWEVER, TWO MONTHS AGO, AVERAGED 740 OHMS. PACING IMPEDANCE MEASUREMENTS IN-CLINIC WERE OBSERVED TO BE 530 TO 600 OHMS, HOWEVER, DURING PATIENT ISOMETRICS HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,500 OHMS WERE OBSERVED IN BIPOLAR CONFIGURATION. IN UNIPOLAR CONFIGURATION, MEASUREMENTS WERE 480 OHMS AND SOME NOISE WAS OBSERVED WITH PATIENT ISOMETRICS. THE PHYSICIAN PLANNED TO PROGRAM THE LEAD TO UNIPOLAR PACING AND BIPOLAR SENSING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311734 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4479

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR 4456| S404| 4479