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

Catalog Number 82-3111

Device Problem Programming Issue (3014)

Patient Problem No Information (3190)

Event Date 12/05/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the chpv pressure couldn¿t be adjusted (changed) on (b)(6) 2016 with vp shunt.The same issue with the previous valve was noted with the patient in the past, and the patient had a revision surgery with chpv at this reported hospital in 2014.During the patient¿s checkup at an outpatient division, the patient was diagnosed as inph, and this issue was detected when the doctor tried to adjust the pressure.The revision with certas was done to the patient on (b)(6) 2016 and it was reported that the impact to the patient¿s condition is minor.These all product information and setting information were provided by hospital.

Manufacturer Narrative

(b)(4).Upon completion of the investigation it was noted that the images were taken of the ¿as received¿ valve.The valve was visually inspected: a needle hole in over the needle guard was noted.The position of the cam when valve was received was 110mmh2o.The valve was hydrated for 24 hours.The valve was tested for programming with programmer 82-3126 with serial number (b)(4), the valve passed the test.The valve was flushed, the valve passed the test no occlusion was noted.The valve was leak tested, only leaked from the needle hole over the needle guard.The valve was reflux tested, the valve passed the test.The valve was dried.The valve was then pressure tested, the valve passed the test.Review of the history device records confirmed the valve product code 82-3111 with lot cplcbz, conformed to the specifications when released to stock in 17th october 2013.No root cause could be determined, as the problem reported by the customer could not be duplicated.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 case postale; le locle ; SZ
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6215867
• MDR Text Key: 63652473
• Report Number: 1226348-2016-10884
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974739
• 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: 12/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 82-3111
• Device Lot Number: CPLCBZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2013
• 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