Udi: unknown part number, udi unavailable.It has been communicated that the device and/or lot information is not available for evaluation.Without the device and/or lot information it is not possible for codman to conduct a proper investigation.If at some point the device and/or lot information does become available, this complaint will be re-opened, evaluated and a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.Device not available.
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The surgeon reported on (b)(6) 2016, that the function of chpv pressure setting is uncontrollable.The chpv was implanted to the patient at an unknown hospital (doi and initial setting was unknown).The patient was examined at the reported hospital and the surgeon set the pressure at 100mmh2o at first.However, the pressure kept changing randomly to 110 to 70 to 40 to 70.It finally stopped at 70mmh2o, and the surgeon decided to observe at this value.The programmer was checked by sales reps and it functioned without problem, so the valve was suspected as the problem.Now the patient condition is being observed at the pressure of 70mmh2o.No further information was provided by hospital.
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