MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN HAKIM PROGRAMMABLE VALVE; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number NS-9008

Device Problems Device Difficult to Program or Calibrate (1496); Obstruction of Flow (2423)

Patient Problems Failure of Implant (1924); Neurological Deficit/Dysfunction (1982)

Event Date 02/13/2019

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: CODMAN HAKIM PROGRAMMABLE VALVE
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; rue girardet 29; le locle CH 24 00; SZ CH 2400
• MDR Report Key: 8379908
• MDR Text Key: 137507781
• Report Number: 1226348-2019-10150
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K974739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: NS-9008
• Device Lot Number: CVBCRB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2019
• Date Manufacturer Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other