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

Catalog Number 82-3162

Device Problem Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 06/11/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported by the sales rep, 2 days after being implanted, an inline precision valve was revised because it wasn't working.They initially planned to implant a programable inline valve, but the siphonguard appeared not to work, so they put it aside and implanted another programable inline valve instead.Both valves involved in this incident will be returned.No delays or adverse reported.

Manufacturer Narrative

(b)(4).Upon completion of the investigation it was noted that the images were taken of the ¿as received¿ valve.The position of the cam when valve was received was 30mmh2o.The valve was visually inspected: no defects were noted.The valve was hydrated.The siphon guard was tested.The valve passed the test.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, no leaks noted.The valve was reflux tested.The valve passed the test.The valve was dried.The valve was not pressure tested as the problem was with the siphon guard.Review of the history device records confirmed the valve product code 82-3162 with lot cvkbr8, conformed to the specifications when released to stock in 23rd september 2016.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 INLINE PROGRAMMABLE VALVE SG
• 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: 6697653
• MDR Text Key: 79522240
• Report Number: 1226348-2017-10483
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• 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: 07/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 82-3162
• Device Lot Number: 126510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2017
• 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
• Treatment: 825462