MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CSF-FLOW CONTROL VALVE, BURR HOLE, 12 MM, MEDIUM PRESSURE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 42534

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/20/2017

Event Type  malfunction  

Event Description

It was reported there was no flow through the valve when the nurse did the testing prior to implant.The valve was replaced and there was no injury to the patient.

Manufacturer Narrative

The returned valve was patent.It met the requirements for reflux, pressure-flow, preimplantation, and leak testing.Therefore the conditions of the complaint could not be duplicated by laboratory personnel.The instructions for use that accompany the device instruct that when performing the patency check: a.Place the inlet connector of the valve into sterile isotonic saline.B.Depress the valve dome.C.Place a finger over the opening at the end of the outlet connector.D.Release the depressed dome.If fluid enters the reservoir, the inlet connector and flow control membrane valve are patent.* e.Remove finger from the outlet connector opening.F.Depress dome.If fluid flows out of the outlet connector, the valve is patent.* * note: it may be necessary to depress the valve dome more than once to initiate flow, especially if the ventricular catheter has been attached prior to patency testing.All valves are 100% tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CSF-FLOW CONTROL VALVE, BURR HOLE, 12 MM, MEDIUM PRESSURE
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 6964482
• MDR Text Key: 90214711
• Report Number: 2021898-2017-00526
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00643169466067
• UDI-Public: 00643169466067
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K831678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: 42534
• Device Catalogue Number: 42534
• Device Lot Number: E00783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2015
• 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