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

Catalog Number 82-3113

Device Problem Decrease in Pressure (1490)

Patient Problem No Information (3190)

Event Date 12/08/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A chpv valve was implanted in 2009 by the clinician at (b)(6) hospital.Patient has had an arachnoid cyst and had an mri and the valve moved from its setting of 100 to 60.The surgeon and resident tried to reprogram the patient in clinic but were unable to move it.She came to the er on (b)(6) 2016 where they tried again under fluoroscopy but it was unsuccessful.The valve was explanted today (b)(6) 2016 and they implanted another valve (medtronic).No adverse, device will be returned.

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 30mmh2o.The valve was visually inspected: no defects were noted.The valve was hydrated for 24 hours.The valve was tested for programming with programmer 82-3126 with serial number (b)(4) and programmer 82-3190 with serial number (b)(4), the valve failed the test, the cam mechanism did not move during the programming process.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 then pressure tested at 30mmh2o, the valve passed the test.The valve was dismantled and was examined under microscope at appropriate magnification: biological debris was found on the spring, on the spring pillar, on the cam mechanism, and on the base plate.The cam magnets were also controlled.The magnets failed.The polarity of the magnets was tested, the magnets were all on ( - ) failed.Review of the history device records confirmed the valve product code 82-3113 with lot cnhbz3, conformed to the specifications when released to stock in 12th december 2007.The root cause of the problem reported by the customer was due to abnormal polarization of chpv magnets this abnormal polarization was probably caused by magnetic fields, this however could not be confirmed.The chpv knockdown evaluation test was documented through dra.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 PROGRAMMABLE VALVE
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29 case postale; le locle ; SZ
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6218383
• MDR Text Key: 63730720
• Report Number: 1226348-2017-10005
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980778
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• 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: 01/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2012
• Device Catalogue Number: 82-3113
• Device Lot Number: CHNBZ3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2007
• 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: 4 MO