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

Catalog Number 82-3100

Device Problem Programming Issue (3014)

Patient Problem No Information (3190)

Event Date 10/31/2017

Event Type  Injury  

Manufacturer Narrative

Udi: product made prior to compliance date, udi unavailable.Upon completion of the investigation, a follow up report will be filed.

Event Description

The valve was implanted to the patient.Doi and initial setting were unk.It was reported that the hydrocephalus symptoms began to be appeared, so the surgeon tried to change the setting but it was not able to be changed.The revision surgery was performed.No further information available.The product will be returned to your site.

Manufacturer Narrative

Device was returned for evaluation.A follow up report will be filed upon completion of the investigation.

Manufacturer Narrative

(b)(4).Upon completion of the investigation it was noted that the images were taken of the ¿as received¿ valve and are attached.The valve was visually inspected; no defects were noted.The position of the cam when valve was received was 140 mmh2o.The valve was hydrated.The valve was tested for programming with programmer 82-3126 with serial (b)(4) and programmer 82-3190 with serial (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 noted.The valve was reflux tested.The valve passed the test.The valve was dried.The valve was then pressure tested at a 140 mmh20, the valve passed.The valve was dismantled and was examined under microscope at appropriate magnification: biological debris was found on the cam mechanism.The cam magnets were also controlled.The magnets failed.The magnets polarity was controlled failed all magnets were on (-).Review of the history device records for the valve product code 82-3100 with lot chncg., conformed to the specifications when released to stock on the 17th december 2007.The root cause for the problem could be due to the biological debris found on the cam mechanism as well as the polarization of the magnets, this however could not be determined.The abnormal polarization of the valve was probably caused by an exposition of a too strong magnetic field.Further details in chpv mri testing conducted.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 WITH PRECHAMBER
• 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: 7075760
• MDR Text Key: 93493063
• Report Number: 1226348-2017-10910
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• 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: 82-3100
• Device Lot Number: CHNCG3
• 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: 01/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2007
• 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