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 Programming Issue (3014)

Patient Problem No Information (3190)

Event Date 12/04/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported by the ous affiliate, a hakim programmable valve was explanted after a patient's clinical condition worsened.After explantation, the valve would not respond to programming.After valve was revised, patient was released with no report of adverse consequences.Additional information is requested.

Manufacturer Narrative

The device has been returned for evaluation.Upon completion of the investigation, 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 170mmh2o.The valve was visually inspected: biological debris was noted inside the valve mechanism, as well as a small mark in the silicone housing not very deep.The valve was hydrated.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.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 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, and on the base plate.Review of the history device records confirmed the valve product code 82-3110, with lot ctjbp2, conformed to the specifications when released to stock in 7th august 2015.The root cause of the problem found during investigation is due to the biological debris found on the spring, on the spring pillar, and on the base plate.The root cause of the mark found in the silicone house, could be due to a sharp or pointed object coming into contact with the silicone, this however could not be determined.As noted in the ifu silicone has a low cut and tear resistance.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; le locle CH 24 00; SZ CH 2400
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 7154478
• MDR Text Key: 96045704
• Report Number: 1226348-2017-11013
• 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: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 82-3110
• Device Lot Number: CTJBP2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2015
• 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