MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. PROGRAMMABLE VALVE IN-LINE W/SIPHONGUARD; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-3832

Device Problems Use of Device Problem (1670); Pressure Problem (3012)

Patient Problems Fever (1858); Coma (2417); Loss of consciousness (2418)

Event Date 10/08/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient is female and (b)(6) years old, had v-p surgery on (b)(6) 2015.Initial pressure is 80 h2o.No anomaly during the procedure.The surgeon adjusted the pressure as 100 h2o according to ct test result on (b)(6) 2015.On (b)(6) 2015 the pressure parameter was adjusted as 90 h2o.The patient had a fever and unconsciousness on (b)(6) 2015.It was noted ventriculomegaly on ct test.On (b)(6) 2015 the parameter was adjusted as 90 h2o.At night the patient was in coma.The surgeon did revision surgery and removed valve.Ventricular external drainage was replaced.Now the patient condition is stable.

Manufacturer Narrative

Upon completion of the investigation it was noted that the position of the cam when valve was received was 70mmh2o.The valve was visually inspected: no defects were noted.The valve was irrigated with purified water, no occlusion was noted.The siphon guard 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, no leaks were noted.The valve was tested for programming.The valve passed the test.The siphon guard was removed.The valve was then pressure tested, the valve passed the test.Review of the history device records confirmed the valve product code 82-3832 with lot crcczw, conformed to the specifications when released to stock on the 10th april 2014.Review of the sterilization certificate for the valve conformed to the specification when released on the 4th april 2014.Review of the history device records confirmed the catheters product code 82-3072 with lot crjbn, conformed to the specifications when released to stock on the 11th july 2014.Review of the sterilization certificate for the bactiseal catheter conformed to the specification when released on the 7th july 2014.No root cause could be determined as the valve functions.No problem was found with the bactiseal catheter.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: PROGRAMMABLE VALVE IN-LINE W/SIPHONGUARD
• 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: 5344171
• MDR Text Key: 35067057
• Report Number: 1226348-2016-10015
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK992173
• 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: 01/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 82-3832
• Device Lot Number: CRCCZW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2014
• 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