BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUITY

    MDR report key: 2910153 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15363
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 2, 2012
    Report Date
    April 13, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THE CLINICAL OBSERVATIONS WITH THE CALLER AND MINIMIZING LV PACE OUTPUTS AND/OR CONSIDERING PROGRAMMING NON-TRACKING MODE IF APPROPRIATE FOR THIS PATIENT. THE CALLER STATED THAT (B)(4) PHYSICIAN MINIMIZED LV PACING OUTPUTS, PROGRAMMED VRR OFF AND PROGRAMMED THE DEVICE TO DDI MODE. THEY WILL CONTINUE TO MONITOR THIS PATIENT AS HE HAD EXPERIENCED A STROKE. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DETAILS WERE RECEIVED STATING THERE WAS NO VISUAL ANOMALIES NOTED ON THE LEAD AND THE DEVICE. 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

    A REVISION PROCEDURE WAS PERFORMED DUE TO THE CONTINUED OUT OF RANGE LV IMPEDANCE MEASUREMENTS. THIS LEAD AND THE ASSOCIATED DEVICE WERE REMOVED FROM SERVICE AND REPLACED. 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 THIS LEFT VENTRICULAR (LV) LEAD WAS EXHIBITING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS. THE CALLER WAS INQUIRING ABOUT HOW TO PROGRAM OFF THIS LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18237 ACUITY IMPLANTABLE LEAD NVY CPI - DEL CARIBE 4555

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR T125| 4555| 4470| N119| 4542