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

Catalog Number 82-3842

Device Problems Decrease in Pressure (1490); Pressure Problem (3012)

Patient Problem No Information (3190)

Event Date 08/20/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2010, the device was implanted via v-p shunt to a patient with congenital hydrocephalus ((b)(6) girl) when she was (b)(6).The initial setting pressure was 200mmh2o.Since slit ventricle was noted 4 years after the implantation, the device was replaced with ns9008 at 200mmh2o on (b)(6) 2015.The surgeon reported that when measured using a manometer, the actual pressure of the device was lower than the setting pressure 200mmh2o.

Manufacturer Narrative

Upon completion of the investigation it was noted that the position of the cam when valve was received was 180mmh2o.The valve was visually inspected: needle holes in the needle chamber 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 valve was dried.The valve was leak tested, only leaked from the needle hole in the needle chamber.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 82-3842 with lot cljbc0, conformed to the specifications when released to stock on the 3rd august 2010.No root cause could be determined as the problem reported by the customer was not confirmed.The valve functions.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 PROG VALVE INLINE SIPHONGUARD
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 5070755
• MDR Text Key: 25559936
• Report Number: 1226348-2015-10516
• 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: Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2013
• Device Catalogue Number: 82-3842
• Device Lot Number: CJCB5D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2008
• 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: 5 YR