BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4884631 · Received July 1, 2015

    Report

    Report Number
    2124215-2015-08497
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    March 25, 2015
    Report Date
    July 9, 2015
    Manufacturer
    CPI PLANT - ST. PAUL
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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). THIS INVESTIGATION IS ONGOING. UPON ADDITIONAL INFORMATION THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP OF THIS PATIENT WITH THIRD DEGREE AV BLOCK A REVIEW OF THE PRINTOUTS AND EXTERNAL ELECTROCARDIOGRAMS NOTED THAT THE DEVICE WAS NOT PACING PROPERLY. IN ADDITION, HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS WERE NOTED ON THE RIGHT ATRIAL (RA) LEAD, WITH NO CAPTURE. REPROGRAMMING DID NOT RESOLVE THE ISSUE. AN INQUIRY WAS SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR REVIEW. TS CONFIRMED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS ON THE RA LEAD AS WELL AS NOISE/OVERSENSING. IN ADDITION SOME NOISE WAS SEEN ON THE RIGHT VENTRICULAR (RV) LEAD. A REVIEW OF THE EXTERNAL ELECTROCARDIOGRAM SHOWED PACING PAUSES WITH A RATE DROPPING BELOW 30 BEATS PER MINUTE. IT WAS NOTED THAT PROVOCATION MANEUVERS WERE PERFORMED BUT IT WAS NOT POSSIBLE TO RECREATED THE PAUSES. TS DISCUSSED PERFORMING A THOROUGH INVESTIGATION OF THE SYSTEM AS WELL AS STORING EPISODES ON THE DEVICE WHICH WOULD HELP FURTHER INVESTIGATION AND DETERMINE THE ROOT CAUSE OF THIS CASE. AT THIS TIME THE SYSTEM REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429258 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI PLANT - ST. PAUL 0693

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR 7741| 4555| G140