Manufacturer statement: for evaluation of the malfunction dhr documents were reviewed.They demonstrate that the catheter neurovent-ifd-r (sn (b)(4)) met specification during manufacturing.Final inspection of the finished catheter was passed.This demonstrates that the catheter has been manufactured and sold in conformance to relevant specifications.The decision of the clinic to applicate a second icp catheter two days after initial application of the n-ifd-r is based on the fact that the n-ifd-r stopped working because of incorrect handling contrary to the ifu so all wires have been torn off.In accordance to the ifu the n-ifd-r has to be removed latest after 5 days.Eventually the implantation period exceeded up to 15 days, in which the leakage problem, again based on incorrect handling contrary to the ifu, occurred after 13 days of implantation, which we consider as off label use.(b)(4).
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The clinic placed an icp/drain (n-ifd-r) on (b)(6) 2019.Then on (b)(6) 2019 inaccurate icp values were reading in the 70's but only straight line no waveform.On (b)(6) 2019 an evd drain was connected to the n-ifd-r, so an icp monitoring was possible and also waveform and readings of 16-18 could be monitored, which is what patient had been reading previously.On (b)(6) 2019 the clinic decided to applicate another icp catheter to obtain accurate continuous icp readings.Left the n-ifd-r in to continue drainage.Then on (b)(6) 2019 the evd connection between n-ifd-r and evd drain came apart and started leaking csf.The clinic decided they need to attempt to repair the leakage as physician felt he would not be able to place another catheter based on the size of the ventricles.The clinic started patient on prophylactic antibiotics.On (b)(6) 2019 the clinic removed the system n-ifd-r / evd.Patient woke up moving extremities.
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