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

Catalog Number 823100

Device Problem Programming Issue (3014)

Patient Problems Headache (1880); Vomiting (2144)

Event Date 02/19/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the valve was implanted to the patient via vp-shunt due to congenital hydrocephaly.Date of implant and initial setting were unknown.It was reported that the patient complained of headache and the vomiting.The pressure setting could not be change as intended since last year and it was unable to be changed at all since (b)(6).The mild headaches continued, so the revision surgery was performed on (b)(6) 2018 with 100 mmh2o.The patient is a (b)(6)-year-old male.Csf protein: unknown.It was suspected of blood and debris contamination in the cerebrospinal fluid.No further information was provided by hospital.

Manufacturer Narrative

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

Manufacturer Narrative

Updated udi : (b)(4).The valve was returned for evaluation.The valve was visually inspected.The valve was tied in the middle; the tie was removed.The position of the cam when valve was received was 80mmh2o.The valve was tested for programming and failed the test; the cam mechanism did not move during the programming process.The valve was flushed; no occlusion noted.The valve was leak tested; no leaks noted.The valve was reflux tested; no issues found.The valve was then pressure tested at 80mmh2o and passed.The silicone was cut just after the cam mechanism, the mechanism was unstuck.The valve was retested for programming and was able to be programmed.The valve was dismantled and was examined under microscope at appropriate magnification: biological debris was found on the on the cam mechanism.Based on the results of the evaluation, the reported issue was able to be confirmed.The root cause of the problem reported by the customer is likely due to the biological debris found on the cam mechanism.Trends will be monitored for this and similar issues.At present, we consider this complaint to be 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
• MDR Report Key: 7318164
• MDR Text Key: 101659785
• Report Number: 1226348-2018-10202
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K974739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 823100
• Device Lot Number: CMLBNW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Date Manufacturer Received: 05/24/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR