BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGEVITY

    MDR report key: 4132148 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-15052
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 24, 2014
    Report Date
    October 9, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION REGARDING THE FINAL DEVICE CHECK ON (B)(6). THE RV PACING IMPEDANCE MEASUREMENT IN UNIPOLAR MODE WAS 1,254 OHMS AND IN BIPOLAR MODE WAS 1,522 OHMS. PACING THRESHOLD MEASUREMENTS IN UNIOPLAR AND BIPOLAR WERE APPROXIMATELY 1.4V @ 0.5MS. R-WAVES MEASURED 9.7MV. THE PATIENT WAS DISCHARGED, WITH ANOTHER FOLLOW UP SCHEDULED OUT FOR THE FOLLOWING WEEK. NO INTERVENTION WAS PERFORMED OR PLANNED. THE TECHNICAL SERVICES CONSULTANT DISCUSSED THAT CONTINUING TO MONITOR WAS APPROPRIATE, AS THE SYSTEM DIAGNOSTICS WERE NORMAL, AND ALSO DISCUSSED THAT A LEAD TIP-TO-TISSUE INTERFACE COULD BE THE CAUSE OF THE ACUTE HIGH IMPEDANCE BEHAVIOR THAT SEEMED TO HAVE STABILIZED SEVERAL DAYS POST-IMPLANT. THE LEAD AND DEVICE REMAIN IN SERVICE. 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

    (B)(4).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, THIS RIGHT VENTRICULAR (RV) LEAD AND ASSOCIATED PACEMAKER EXHIBITED HIGHER THAN EXPECTED PACING IMPEDANCE MEASUREMENTS. MEASUREMENTS BETWEEN 1,422 OHMS AND 1,700 OHMS WERE OBSERVED. ONE DAY POST-IMPLANT ((B)(6)), THE PACING IMPEDANCE MEASUREMENT WAS GREATER THAN 2,000 OHMS. DEVICE DATA AND X-RAYS WERE SUBMITTED TO TECHNICAL SERVICES FOR REVIEW. THE TRUE PACING IMPEDANCE MEASUREMENT ONE DAY POST-IMPLANT WAS 2,550 OHMS. THE X-RAY REVEALED THE TERMINAL PIN WAS NOT FULLY INSERTED INTO THE DEVICE HEADER. THE FOLLOWING DAY ((B)(6)), THE DEVICE WAS CHECKED AGAIN. THE IMPEDANCE MEASUREMENTS WERE GREATER THAN 2,000 OHMS IN BOTH UNIPOLAR AND BIPOLAR CONFIGURATIONS. THE TRUE IMPEDANCE MEASUREMENT WAS 2,252 OHMS; PACING THRESHOLD MEASUREMENTS WERE VERY GOOD AT [email protected]. HOWEVER, LEAD MEASUREMENTS TAKEN THREE DAYS LATER ((B)(6)) FOUND THE IMPEDANCE MEASUREMENTS TO BE IMPROVING, WITH UNIPOLAR IMPEDANCE ABOUT 1,300 OHMS AND BIPOLAR IMPEDANCE ABOUT 1,500 OHMS, WHILE THE PACING THRESHOLD MEASUREMENTS WERE INCREASING, TO 1.1V IN BIPOLAR AND 1.5V IN UNIPOLAR. THE PHYSICIAN WANTED TO CONTINUE TO MONITOR THE LEAD MEASUREMENTS, AND ANOTHER DEVICE CHECK WAS PLANNED FOR (B)(6). NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611265 INGEVITY IMPLANTABLE LEAD NVN CPI - DEL CARIBE 7742

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR J175| 7742