Catalog Number NS-9008 |
Device Problems
Device Difficult to Program or Calibrate (1496); Obstruction of Flow (2423)
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Patient Problems
Failure of Implant (1924); Neurological Deficit/Dysfunction (1982)
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Event Date 02/13/2019 |
Event Type
Injury
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Manufacturer Narrative
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Udi: (b)(4).It has been reported that the device will be returned for evaluation.Upon receipt of the device or additional relevant information, a follow-up report will be submitted.
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Event Description
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T was reported that the valve was implanted via lp.The doi and the initial setting was unknown.The symptom of difficulty with walking was improved after the implant.After a while the surgeon experienced difficulty in changing the setting.The symptom of difficulty with walking appeared again and this time s/he suspected that the valve does not function well, also the valve could be obstructed.Therefore a revision surgery was performed.No further information was provided by the hospital.The product will be returned to your site.
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Manufacturer Narrative
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Udi (b)(4).The device was returned for evlauation.The position of the cam when valve was received was 100mmh2o.The valve was visually inspected: no defects noted.The valve was hydrated and tested for programming; the valve passed the test.The valve was flushed; no occlusion was noted.The valve was leak tested; no leaks noted.The valve was reflux tested and passed.The siphon guard was tested and passed.The valve was dried and the siphon guard was removed.The valve was then pressure tested; no issues found.A review of manufactuirng records found the device conformed to specification when released to stock.Based on the results of the investigation, the rpeorted issue could not be confirmed.The device functioned as intended.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
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Search Alerts/Recalls
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