MAUDE Adverse Event Report: HAKIM PROGRAMMABLE VALVE; CNS SHUNT

Catalog Number 82-3111

Device Problem Device Difficult to Program or Calibrate (1496)

Patient Problem Failure of Implant (1924)

Event Date 10/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

As reported by the ous affiliate, approximately 15 years after implant, a hakim valve can not be reprogrammed.The patient has undergone a lot of mri's and was revised.

Manufacturer Narrative

Udi: (b)(4).The device was returned for evaluation.The position of the cam when the valve was received was at 200mmh2o.The valve was visually inspected; it was noted that the x ray dot was dislodged as well as a crack and bump mark in the valve casing, the x ray dot was sitting on the cam mechanism.The valve was tested for programming and failed.The cam mechanism did not move during the programming process.The silicone was cut just after the cam mechanism, the mechanism was unstuck.The x ray dot was removed from the cam mechanism.The valve was retested for programming and passed.The valve was dismantled and was examined under a microscope at appropriate magnification: a crack and bump mark were noted in the valve casing.This is probably due to the valve receiving a hard knock.Corrosion was also noted on the x ray dot.A review of manufacturing records found that the device conformed to specification when released to stock.The root cause for the programming issue was probably due to the x ray dot on the cam mechanism.The root causes for the dislodged x ray dot could be partly due to the valve receiving a hard knock.The root cause for the crack and bump mark in the valve casing is due to the valve receiving a hard knock.The root cause of the corrosion could not be clearly determined.Trauma to the valve, whether it occurs while implanted or at explant, was the root cause of stator dislodgement.Galvanic corrosion could not be established as a direct root cause for those valves investigated, however it was found to be a contributing factor when trauma to the valve was found.Corrosion, when it arises, only arises after long term exposure to csf.Based on the results of the investigation, the reported issue is confirmed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: HAKIM PROGRAMMABLE VALVE
• Type of Device: CNS SHUNT
• MDR Report Key: 8106157
• MDR Text Key: 128419046
• Report Number: 1226348-2018-10813
• 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: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2008
• Device Catalogue Number: 82-3111
• Device Lot Number: 1092367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2018
• Date Manufacturer Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other