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

Catalog Number 82-3101

Device Problems Partial Blockage (1065); Break (1069); Programming Issue (3014)

Patient Problem Edema (1820)

Event Date 01/25/2018

Event Type  Injury  

Manufacturer Narrative

Product made prior to compliance date, gtin unavailable; (b)(4).Upon completion of the investigation a follow up report will be filed.

Event Description

The valve was implanted to the patient via vp-shunt on (b)(6) 2017 because the ventricle become to be bigger.Initial setting was unknown.After that, the edema occurred although it was set as low as 70 mmh2o.It was reported that the pressures setting was not able to be changed when the surgeon tried to change the setting.The revision removal surgery was performed on (b)(6) 2018.The surgeon commented that it was suspected the biological component was clogged or the valve was broken.The patient¿s information was not available.No further information was provided by the hospital.The product will be returned to your site.

Manufacturer Narrative

The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

The device was returned for evaluation.The valve was visually inspected; a crack and bump mark in the valve casing was noted and the proximal connector end of the valve was cut off (the connector was not returned).The position of the cam when valve was received was 30mmh2o.The valve was tested for programming and failed the test.The cam mechanism did not move during the programming process.The valve was dismantled and was examined under microscope at appropriate magnification: the cam mechanism was moved slightly.The valve was then re-tested for programming and passed.A crack and a bump mark was noted in the valve casing.Biological debris was found on the cam mechanism.Review of the device history record for the valve confirmed the valve met specification when released to stock.The root cause for the programming problem was like due to biological debris as once the cam was unstuck the valve could be programmed.The root cause for the crack and bump mark in the valve casing was probably due to the valve receiving a hard knock.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: HAKIM PROGRAMMABLE VALVE WIHOUT PRECHAMBER
• 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
• MDR Report Key: 7293781
• MDR Text Key: 100843098
• Report Number: 1226348-2018-10182
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K974739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 82-3101
• Device Lot Number: CTPBCN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Date Manufacturer Received: 04/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention