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

Catalog Number 82-3112

Device Problems Partial Blockage (1065); Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 09/28/2017

Event Type  Injury  

Manufacturer Narrative

Udi: product made prior to compliance date, gtin unavailable.Upon completion of the investigation a follow up report will be filed.

Event Description

The valve stopped to work probably due to a block of the knob.It was replaced.Revision surgery was necessary+ antibiotic therapy.Patient gender: m.There was no report of infection despite use of antibiotic therapy.

Manufacturer Narrative

(b)(4).Correction to the alert date.It was reported in mfr # 1226348-2017-10775 as being sep 27, 2017; however, the corrected date is sep 28, 2017.Correction also to the 510(k) # and udi #.Upon completion of the investigation a followup report will be filed.

Manufacturer Narrative

(b)(4).The device was returned for evaluation.The position of the cam when valve was received was 150 mmh2o.The valve was visually inspected; biological debris was noted inside the valve.The valve was tested for programming and passed without issue.The valve was flushed, no occlusion was noted.A leak test was performed and passed.A reflux was performed and failed.The valve was then dried and pressure tested.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 and on the base plate.Review of the history device records confirmed the valve product code 82-3112, with lot clhbj2 conformed to specifications when released to stock.Based on the evaluation of the device, the reported issue was confirmed.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 ruby ball, on the seat of the ruby ball, on the cam mechanism, on the cam mechanism, and on the base plate.Trends will be monitored for this or similar complaints.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: 6960565
• MDR Text Key: 89676041
• Report Number: 1226348-2017-10775
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980778
• 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: 06/30/2015
• Device Catalogue Number: 82-3112
• Device Lot Number: CLHBJ2
• 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: 09/28/2017
• Initial Date FDA Received: 10/18/2017
• Supplement Dates Manufacturer Received: 09/28/2017; 12/13/2017
• Supplement Dates FDA Received: 10/18/2017; 12/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2010
• 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