MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM VALVE INLINE UNIT (INTEGRAL CON); SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-3844

Device Problems Sticking (1597); Device Dislodged or Dislocated (2923); Pressure Problem (3012)

Patient Problem Headache (1880)

Event Date 01/28/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The device was implanted via v-p shunt to a (b)(6) female.Doi and the initial setting pressure are unknown.After implantation, the patient had a minor headache.The surgeon tried to change the setting pressure, but it could not be changed even by using neodymium.The device was replaced with the same new product at 90mmh2o on (b)(6) 2016, and the patient's condition improved.The indicator of the valve is positioned between 30mmh2o and 200mmh2o, so the surgeon suspects the cam dislodgement or the valve becoming stuck at the home position due to biological debris.

Manufacturer Narrative

Upon completion of the investigation it was noted that the position of the cam when valve was received was 30mmh2o.The valve was visually inspected: no defects were noted.The valve was tested for programming.With programmers 82-3126 sn (b)(4) and 82-3190 sn (b)(4), the valve failed the test, during the programming process the cam mechanism did not move.The valve was irrigated with purified water.An occlusion was noted at the inlet of the ruby ball.Therefore a fine needle was inserted into the flow opening of the valve inlet under the ruby ball and its seat, the ruby ball was manually popped free from its stuck position using light force.The valve was irrigated again, no occlusion was noted.The catheters were irrigated with purified water, no occlusion was noted.The valve was dried.The valve was leak tested, no leaks were found.The valve was reflux tested, the valve passed the test.The valve was retested for programming.With programmer 82-3126 sn (b)(4) and 82-3190 sn (b)(4), the valve failed the test, during the programming process the cam mechanism did not move.The valve was then pressure tested at 30mmh2o, 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, on the cam mechanism, on the cam mechanism pillar, and on the base plate.The cam magnets were also controlled.The magnets passed.The lot history record was reviewed for completeness during the release process to inventory.At that time based on the fact that no discrepancies were noted for the products being accepted, they were released to stock on the 22nd june 2006.The root cause of the problem reported by the customer is due to biological debris found on the spring, on the spring pillar, on the ruby ball, on the seat of the ruby ball, on the cam mechanism, on the cam mechanism pillar, 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 VALVE INLINE UNIT (INTEGRAL CON)
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; ch-2400 le locle ; SZ
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 5444039
• MDR Text Key: 38445476
• Report Number: 1226348-2016-10125
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK974739
• 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: 02/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2011
• Device Catalogue Number: 82-3844
• Device Lot Number: CGGB85
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2006
• 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: 78 YR