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

Catalog Number 82-3113

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Customer reported rotor dislocated.Device revised (b)(6) 2017.

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).The valve was returned for evaluation.The valve was visually inspected: stator and x-ray dot were dislodged of the baseplate, therefore; the cam position/pressure could not be determined.The valve was flushed and no occlusion was noted.The valve was leak tested; no leaks were found.The valve was reflux tested; the valve failed the test.The catheters were irrigated, with no occlusion or leakage noted.The valve was dismantled and was examined under microscope at appropriate magnification: stator and x-ray dot were dislodged of the base plate.Bumps mark were noted in the valve casing.This is likely due to the valve receiving a hard knock.Corrosion was also noted on the stator.The cam magnets were controlled and passed testing.The lot history record was reviewed for completeness during the release process to inventory.No discrepancies were noted for the products being accepted when released to stock.The stator dislodgement of chpv has been previously investigated.The investigation concluded that several factors may contribute to the stator dislodgement.Trauma to the valve, whether it occurs while implanted or at explant, was the root cause of stator dislodgement.Galvanic corrosion could not be established as a direct root cause for those valves investigated, however it was found to be a contributing factor when trauma to the valve was found.Corrosion, when it arises, only arises after long term exposure to csf.This issue will continue to be monitored through monthly complaint trending and the post market surveillance process.At present, we consider this complaint to be closed.

• Brand Name: HAKIM PROGRAMMABLE MICRO VALVE
• 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: 6909061
• MDR Text Key: 87989678
• Report Number: 1226348-2017-10723
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053107
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2011
• Device Catalogue Number: 82-3113
• Device Lot Number: CGNB70
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2017
• Initial Date FDA Received: 10/02/2017
• Supplement Dates Manufacturer Received: 10/10/2017; 12/01/2017
• Supplement Dates FDA Received: 10/16/2017; 12/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2007
• 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