MAUDE Adverse Event Report: JOHNSON AND JOHNSON PROFESSIONAL, INC. / MEDOS S.A HAKIM PROGRAMMABLE VALVE; CNS SHUNT

Catalog Number 82-3111

Device Problems Occlusion Within Device (1423); Insufficient Flow or Under Infusion (2182)

Patient Problems Headache (1880); High Blood Pressure/ Hypertension (1908); Vomiting (2144)

Event Date 03/07/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2011, the device was implanted via v-p shunt to a patient with a brain tumor ((b)(6) female).The initial pressure setting was unknown.On (b)(6) 2016, the patient had a persistent headache and vomiting (about 5 times).On (b)(6) 2016, she was immediately hospitalized, and intracranial hypertension and consciousness disorder were noted.Using contrast radiography, csf flow through the ventricular catheter was confirmed, but the prechamber was slow to respond when pumping.Since fluid flowed through the distal catheter without any problem, the surgeon suspected occlusion at the proximal end including the valve and performed an emergency revision on the same day.The device was replaced with the same new product set at 140mmh2o.The setting of the removed valve was 140mmh2o.When checking the removed valve using a manometer, poor fluid flow was confirmed even at the setting of 300mmh2o.After the revision, the patient recovered and was discharged from the hospital on (b)(6) 2016.

Manufacturer Narrative

Upon completion of the investigation, it was noted that the position of the cam when valve was received was 110mmh2o.The valve was visually inspected, needle holes over the needle guard were noted.The valve was irrigated with purified water.No occlusion was noted.The catheter was irrigated with purified water, no occlusion was noted.The valve was dried.The valve was leak tested, only leaked from the needle holes over the needle guard.The valve was reflux tested, the valve failed the test.The valve was tested 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 110mmh2o, the valve failed.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.Review of the history device records confirmed the valve product code 82-3111 with lot cmcc2z, conformed to the specifications when released to stock in 25th march 2011.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 PROGRAMMABLE VALVE
• Type of Device: CNS SHUNT
• Manufacturer (Section D): JOHNSON AND JOHNSON PROFESSIONAL, 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: 5544497
• MDR Text Key: 41760894
• Report Number: 1226348-2016-10257
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: 82-3111
• Device Lot Number: CMCC2Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/15/2016
• Initial Date FDA Received: 04/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2011
• 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: 17 YR