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

Catalog Number 82-3110

Device Problem Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 11/16/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

We received a product complaint from venezuela, however, we have not the product information (name; code; lot).We only received the event below: ¿patient, after four (4) years of implanted valve, presumably there was a problem with the reservoir, which was a codman product.¿ per affiliate: the patient has a programable hakim valve implanted for 3 years.In a period of 4 months approximately began to have problems, the first time was reprogrammed and the second one removed.The patient with progressive impairment of cognitive functions and their hakim symptoms, gait and urinary incontinence.The doctor considered that the reservoir was not working and proceeded to removed the implant.

Manufacturer Narrative

It was initially reported that the device would be returned.It was later communicated that the device would not be made available for evaluation.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.At present, we consider this complaint to be closed.

Manufacturer Narrative

It was previously reported that the device would not be made available for evaluation.The valve was subsequently returned.Upon completion of the evaluation, a follow-up report will be submitted.

Manufacturer Narrative

It was previously reported that the device would nto be made available for evaluation.The valve was subsequently returned.Upon completion of the evaluation, a follow-up report will be submitted.

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 70 mmh2o.The valve was hydrated.The valve was visually inspected; biological debris was noted.The valve was tested for programming with programmer 82-3126 with serial number (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 valve was reflux tested.The valve failed the test.The valve was dried.The valve was then pressure tested, the valve failed 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 ruby ball, on the seat of the ruby ball, and on the base plate.Review of the history device records for the valve product code 82-3110, with lot cpdbh0 conformed to the specifications when released to stock on the 16th may 2013.The root cause of the problem reported by the customer is due to the biological debris found on the spring, on the spring pillar, on the ruby ball, on the seat of the ruby ball, and on the base plate.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 W/PRECHAMBER
• 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: 6218316
• MDR Text Key: 63728040
• Report Number: 1226348-2017-10004
• 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,Followup,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: 03/31/2018
• Device Catalogue Number: 82-3110
• Device Lot Number: CPDBH0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2013
• 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