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

Catalog Number 82-3164

Device Problem Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 03/10/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported by sales rep, valve stopped working several months after implantation; explanted today.

Manufacturer Narrative

(b)(4).Upon completion of the investigation it was noted that the images were taken of the valve ¿as received¿.The valve was visually inspected: biological debris was noted inside the valve casing, as well as needle holes in the needle chamber.The position of the cam when valve was received was not visible due to the biological debris.The valve was hydrated.The valve was could not be program tested due to the biological debris covering the cam mechanism.The valve was flushed, the valve passed the test no occlusion was noted.The valve was leak tested, only leaked from the needle holes in the needle chamber.The valve was reflux tested.The valve failed the test.The valve was dried.The valve could not be pressure tested due to the biological debris covering the cam mechanism.The valve was dismantled and was examined under microscope at appropriate magnification: biological debris was found covering the valve mechanism.Review of the history device records confirmed the valve product code 82-3164, with lot cvjb4p, conformed to the specifications when released to stock on the 9th september 2016.The root cause of the problem reported by the customer is due to the biological debris found covering all of the valve¿s mechanism.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 IN LINE PROGRAMMABLE VALVE
• 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: 6453355
• MDR Text Key: 71527481
• Report Number: 1226348-2017-10226
• 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
• 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: 04/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 82-3164
• Device Lot Number: CVJB4P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2016
• 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