CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
|
Back to Search Results |
|
Catalog Number 82-3100 |
Device Problems
Insufficient Flow or Under Infusion (2182); Device Dislodged or Dislocated (2923)
|
Patient Problem
Headache (1880)
|
Event Date 08/09/2016 |
Event Type
Injury
|
Manufacturer Narrative
|
Udi: gtin unavailable, product made prior to compliance date upon completion of the investigation a follow up report will be filed.
|
|
Event Description
|
The device was implanted via v-p shunt to a patient with congenital hydrocephalus on (b)(6) 2004 when he was (b)(6); now he is (b)(6).The initial pressure setting was 90 mm h2o.In 2013, although the white marker was found dislodged, csf flow was confirmed and setting change was done under fluoroscopy, so the surgeon kept monitoring the patient.On (b)(6) 2016, the patient visited the hospital due to mild headache, and it was found through mri that the ventricles of the patient's brain became large and csf flow was reduced.The surgeon tried to reprogram the setting, but it could not be changed.Therefore, the surgeon replaced the device with the same new product set at 90 mm h2o on (b)(6) 2016.The patient's condition is good after the revision.The surgeon requested to investigate the root cause of the white marker dislodgement and provide evidence of 3.0 tesla mri resistance test.
|
|
Manufacturer Narrative
|
(b)(4).Upon completion of the investigation it was noted that the valve was visually inspected it was noted that the stator and x-ray dot were dislodged.Therefore; the cam position/pressure could not be determined.The valve was hydrated for 24 hours.The valve was flushed, the valve passed the test no occlusion was noted.The valve was leak tested, no leaks were noted.The valve was reflux tested.The valve passed the test.The valve was dried.The valve was dismantled and was examined under microscope at appropriate magnification: a crack and a scratch mark were noted in the valve casing.This is probably due to the valve receiving some form of impact.Corrosion was noted on the stator.The cam magnets were controlled.The magnets passed.The lot history record was reviewed for completeness during the release process to inventory.At that time based on the fact that no discrepancies were noted for the products being accepted, they were released to stock on the 23rd july 2003.The root cause of the corrosion could not be clearly determined.The root causes for the dislodged stator and x-ray dot could be partly due to the valve receiving a hard knock, as well as the corrosion.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.
|
|
Search Alerts/Recalls
|
|
|