BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY

    MDR report key: 2780017 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12059
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    July 30, 2012
    Report Date
    September 6, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP, THIS LEFT VENTRICULAR (LV) LEAD WAS NOTED TO HAVE A PRODUCT PERFORMANCE ISSUE. WHEN A PACING VECTOR WAS USED THAT INCLUDED THE LV RING, OUT OF RANGE PARAMETERS WERE SEEN. PACING IMPEDANCE WAS HIGH AND OUT OF RANGE AND THERE WAS NO CAPTURE AT MAXIMUM OUTPUT. WHEN A DIFFERENT VECTOR WAS CHOSEN THAT UTILIZED THE LV TIP TO RV RING, THIS WAS FOUND TO HAVE NORMAL IMPEDANCE AS WELL AS CAPTURE IN THE LEFT VENTRICLE. NORMAL BI-VENTRICULAR PACING WAS ACHIEVED IN THIS VECTOR. THERE WAS NO REPORT OF NOISE ON THE EGM, AND AN X-RAY SHOWED NO SIGNS OF LEAD MOVEMENT. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT WAS CONTACTED WITH REGARD TO THIS ISSUE. TS SAID THAT THE OBSERVATIONS SEEN WITH THIS LEAD COULD BE INDICATIVE THAT THE LEAD IS NOT OPTIMALLY INSERTED IN THE DEVICE HEADER (DEVICE MODEL/SERIAL P108/(B)(4)). IN SUCH SITUATION, THE TIP ELECTRODE COULD STILL MAKE CONTACT WITH THE CONNECTOR BLOCK. THIS WOULD ALLOW TO USE IT FOR PACE/SENSE CONFIGURATION (AS DESCRIBED IN THE HOSPITAL FORM: LV TIP TO RV RING/COIL). THE PATIENT WAS NOTED TO HAVE RARE DIAPHRAGMATIC TWITCH AT OUTPUTS ABOVE 3V @ 0.8MS, HOWEVER THIS SETTING PROVIDED THE BEST PARAMETERS, SO IT WAS LEFT AND THE PATIENT WAS ADVISED TO CONTACT THE CLINIC IF ANY ISSUES WERE OBSERVED. THERE IS NO PLAN TO REPLACE THIS LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4555

    Patients

    Seq Age Sex Outcome Treatment
    1