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  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

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.Therefore the conditions of the complaint could not be duplicated by laboratory personnel.It met the requirements for reflux, and leak testing.However, the valve did not meet requirements for pressure-flow, and pre-implantation testing.There was crystalline debris noted within the interior and exterior of the valve.Debris within the valve may hold pressure-flow controlling mechanisms open affecting the flow of fluid through the valve and may result in fluid reflux.The instructions for use (ifu) that accompany the device caution that ¿shunt obstruction may occur in any of the components of the shunt system.The system may become occluded internally due to tissue fragments, blood clots, tumor cell aggregates, bacterial colonization, or other debris.¿ 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: 6964480
• MDR Text Key: 90570007
• Report Number: 2021898-2017-00525
• 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