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 Problem
Programming Issue (3014)
|
Patient Problem
No Information (3190)
|
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Upon completion of the investigation, a follow up report will be filed.
|
|
Event Description
|
As reported by the ous affiliate, a hakim programmable valve could not be reprogrammed, so it was explanted.
|
|
Manufacturer Narrative
|
It was previously reported that the device would be returned for evaluation.Multiple attempts to obtain the sample were not successful.This report has been updated to reflect the corrected information.Complaint sample was not returned to codman and no lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.
|
|
Manufacturer Narrative
|
Udi: (b)(4).The device was returned for evaluation.The position of the cam when valve was received was 40mmh2o.The valve was visually inspected: no defects noted.The valve was tested for programming and 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 test.The valve was then pressure tested; no issues found.A review of manufacturing records found the device conformed to specification when released to stock.Based on the results of the investigation, the reported 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.
|
|
Search Alerts/Recalls
|
|
|