MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM PROG VALVE INLINE SIPHONGUARD; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-3842

Device Problems Excess Flow or Over-Infusion (1311); Migration or Expulsion of Device (1395); Device Damaged Prior to Use (2284); Programming Issue (3014)

Patient Problem No Information (3190)

Event Date 12/26/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

In 2011, the valve was implanted to the patient with vp-shunt (doi and the initial setting were unk).In 2016, 40mmh2o of over-drainage was noted.The valve was checked by the x-ray, and it was noted that parts inside of the valve were not in their expected position (location).Also the setting was unable to change.The patient¿s condition was observed without removing the valve.However, on (b)(6) 2016, the revision was performed with a medtronic strata.The final setting of the removed valve was 40mmh2o.The initial setting of the strata was 110mmh2o.The patient¿s condition has not been changed and is currently being observed.The patient¿s initial is (b)(6), and he is an (b)(6) year old boy.The patient was suffering from congenital hydrocephalus.The surgeon suspected the valve got damaged during implant.No further information was provided by the hospital.

Manufacturer Narrative

(b)(4).Upon completion of the investigation, it was noted that the valve was visually inspected it was noted that the stator and x ray dot were dislodged.Therefore; the cam position/pressure could not be determined.The valve was hydrated for 24 hours.The valve was flushed, the valve passed the test no occlusion was noted.The valve was leak tested, no leaks were noted.The valve was reflux tested, the valve passed the test.The siphon guard was tested, the valve passed the test.The valve was dried.The valve was dismantled and was examined under microscope at appropriate magnification: a crack and a scratch mark were noted in the valve casing.This is probably due to the valve receiving some form of impact, this however could not be determined.Corrosion was noted on the stator and the x ray dot.The cam magnets were controlled.The magnets passed.Review of the history device records confirmed the valve product code 82-3842, with lot chgb5w, conformed to the specifications when released to stock on the 27th june 2007.The root cause of the corrosion could not be clearly determined.The root causes for the dislodged stator could be partly due to the valve receiving some form of impact, as well as the corrosion, this however could not be determined.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 PROG VALVE INLINE SIPHONGUARD
• 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: 6247781
• MDR Text Key: 64712184
• Report Number: 1226348-2017-10040
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992173
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2012
• Device Catalogue Number: 82-3842
• Device Lot Number: CHGB5W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2007
• 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
• Patient Age: 8 YR