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 11/09/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

(b)(6) said that surgeon attempt to re-program the setting of the valve but failed for many times.After checking the patient record, the valve was implanted many years ago and previous re-program failed as well.Recently, the valve is taken out and replaced with another similar one.It is observed that there is something stuck in the valve which led to malfunctioning of the valve and fail to program.P.S.Product code suspected to be (b)(4) but unable to input via unity.Patient consequence? :yes.Patient consequence description: hydrocephalus not resolved with failed re-programming action taken for procedure: reoperated to replace with another valve.

Manufacturer Narrative

The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

Corrected udi: device was made prior to compliance date, gtin unavailable; (b)(4).Upon completion of the investigation it was noted that the images were taken of the ¿as received¿ valve.The valve was visually inspected; biological debris was noted inside the valve.The position of the cam when valve was received was 180 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 passed.The valve was leak tested, no leaks noted.The valve was reflux tested and passed.The valve was dried.The valve was then pressure tested at 180 mmh2o, passed.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 passed.Review of the history device records for the valve product code 82-3100, with lot 1190401 conformed to the specifications when released to stock on the 3rd june 2004.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 cam mechanism, 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 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: 7075604
• MDR Text Key: 93492867
• Report Number: 1226348-2017-10909
• 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: 05/31/2009
• Device Catalogue Number: 82-3100
• Device Lot Number: 1190401
• 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: 06/03/2004
• 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