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

Catalog Number 82-3112

Device Problem Mechanical Problem (1384)

Patient Problems Neurological Deficit/Dysfunction (1982); Hydrocephalus (3272)

Event Date 04/18/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported by the affiliate, the hakim microvalve had unexpected setting changes after implantation with acute intracranial hypertension and decreased level of consciousness and the device was revised.The shunt was set at 170 mmhg and approximately 2 months later is was noted to be at 120 mmhg.Another similar codman hakim valve was used for the revision.The patient recovered consciousness after the revision surgery.The device will be returned.

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; possible bump mark in valve casing.The position of the cam when valve was received was 120mmh2o.The valve was tested for programming; the valve failed the test, the cam mechanism did not move during the programming process.The valve was flushed, leak tested and reflux tested; no issues found.The valve was then pressure tested at 120mmh2o and passed.The silicone was cut just after the cam mechanism, and the mechanism was turned slightly.The valve was retested for programming; the valve 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: a crack and a bump mark were found in the valve casing, as well as some damage to the cam mechanism steps.The cam magnets were controlled and passed testing.A review of manufacturing records found no discrepancies when the device was released to stock.The root cause of the problem reported by the customer is 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 MICRO 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
• MDR Report Key: 7502474
• MDR Text Key: 107849297
• Report Number: 1226348-2018-10340
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K980778
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 82-3112
• Device Lot Number: 148407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Date Manufacturer Received: 07/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2 MO
• Patient Weight: 5