MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN HAKIM PROGRAMMABLE VALVE; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number NS9008

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 02/22/2019

Event Type  Injury  

Manufacturer Narrative

Udi -- (b)(4).It has been reported that the device will be returned for evaluation.Upon receipt of the device or additional relevant information, a follow-up report will be submitted.

Event Description

It was reported that the valve was implanted via lp in 2016.The doi and the initial setting is unknown.During consultant with the surgeon, it was confirmed by x-ray images that the valve has been turned horizontally in the angle of 90 degrees.The setting was changed, but no improvement confirmed.It has been almost 3 years since the valve was implanted, so a revision surgery was performed on (b)(6) 2019.A certas valve was implanted instead.The concomitant programmer was 82-3190.The score of csf protein was within the range.No permeation of blood or debris to the cerebrospinal fluid was confirmed.No further information was provided by the hospital.The product will be returned to your site.

Manufacturer Narrative

Udi: (b)(4).The device was returned for evaluation.The valve was visually inspected: it was noted that the valve casing has been pushed forwards in the silicone housing and is tilted inside the silicone housing.The position of the cam when valve was received was 140mmh2o.All programmable devices are programmed just before going into stock and this is when the device is packed in the sealed blisters.If the valve casing was turned or pushed forwards in the silicone housing at this stage of the process it would not have been possible to program the valve, and the valve would be rejected.The root cause could be due to atypical force when flushing the valve this could have expanded the silicone housing giving enough room for the valve casing to move, but this could not be determined.A review of manufacturing records found the device conformed to specification when released to stock.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: CODMAN HAKIM PROGRAMMABLE VALVE
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; rue girardet 29; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 8405498
• MDR Text Key: 138290504
• Report Number: 1226348-2019-10164
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: NS9008
• Device Lot Number: CTGB39
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Date Manufacturer Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR