MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM VALVE; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number NS-9008

Device Problem Programming Issue (3014)

Patient Problem No Information (3190)

Event Date 11/09/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Upon completion of the investigation a follow up report will be filed.

Event Description

The valve was implanted to the patient via lp-shunt on (b)(6) 2015 with setting 90 mm h2o.It was reported that the pressure setting was not able to be changed and shunt failure occurred.Underdrainage was performed but the issue continued.Therefore the revision surgery was performed via vp shunt.The patient's initial (b)(6), female.Primary disease: subarachnoid hemorrhage.No further information available.The product will be returned to your site.

Manufacturer Narrative

(b)(4).Upon completion of the investigation it was noted that the images were taken of the ¿as received¿ valve.The position of the cam when valve was received was 60 mmh2o.The valve was visually inspected: no defects were noted.The valve was hydrated.The valve was tested for programming with programmer 82-3126 with serial (b)(4), the valve passed the test.The valve was flushed, the valve passed the test no occlusion was noted.The valve was leak tested.No leaks noted.The catheter was irrigated, no occlusion noted.The valve was reflux tested.The valve passed the test.The siphon guard was tested.The siphon guard passed the test.The valve was dried.The siphon guard was removed.Review of the history device records confirmed the valve product code ns9008, with lot cvfbwg, conformed to the specifications when released to stock in 13th may 2016.No root cause could be determined; as no problem was noted with the valve.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.

• Brand Name: HAKIM VALVE
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; le locle CH 24 00; SZ CH 2400
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 7084337
• MDR Text Key: 93769737
• Report Number: 1226348-2017-10923
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: NS-9008
• Device Lot Number: CVFBWG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR