MAUDE Adverse Event Report: HAKIM PROGRAMMABLE VALVE W/PRECHAMBER; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-3110

Device Problem Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 01/18/2017

Event Type  Injury  

Manufacturer Narrative

Udi: unknown product code, udi unavailable.Upon completion of the investigation a follow up report will be filed.

Event Description

It was reported that the valve was revised due to malfunction.No specific failure was reported.

Manufacturer Narrative

(b)(4).Upon completion of the investigation, it was noted that the valve was visually inspected it was noted that the stator was dislodged.Therefore; the cam position/pressure could not be determined.The valve was hydrated for 24 hours.The valve was flushed, the valve passed the test no occlusion was noted.The valve was leak tested, no leaks were noted.The valve was reflux tested, the valve passed the test.The valve was dried.The valve was dismantled and was examined under microscope at appropriate magnification: a scratch mark was noted in the valve casing.This is probably due to the valve receiving some form of impact.The cam magnets were controlled.The magnets passed.Review of the history device records confirmed the valve product code 82-3110, with lot ckcbp8, conformed to the specifications when released to stock on the 10th march 2009.The stator dislodgement of chpv was investigated.The investigation concluded that several factors may contribute to the stator dislodgement.Trauma to the valve, whether it occurs while implanted or at explant, was the root cause of stator dislodgement.This issue will continued to be monitored through monthly complaint trending and the post market surveillance process.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 PROGRAMMABLE VALVE W/PRECHAMBER
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6322467
• MDR Text Key: 67133968
• Report Number: 1226348-2017-10095
• 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,foreig
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Catalogue Number: 82-3110
• Device Lot Number: CKCBP8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/18/2017
• Initial Date FDA Received: 02/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2010
• 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