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

Catalog Number 9040 B

Device Problem Inaccurate Flow Rate (1249)

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

Event Date 02/28/2017

Event Type  malfunction  

Manufacturer Narrative

The product was not returned.Therefore an evaluation of the device performance was not possible.A review of the manufacturing records showed no anomalies.All valves are 100% tested at the time of manufacture.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported to medtronic neurosurgery that the physician could not see cerebrospinal fluid (csf) flow inside the valve intra-operatively when they palpating the valve.According to the report, there was flow of csf from the ventricular catheter to the valve.Reportedly, the physician determined the valve was not working properly and replaced it with a different manufacturer¿s valve.There was no injury to the patient.

Manufacturer Narrative

The returned valve was patent and it met all of the requirements for the leakage, reflux, pressure-flow, and preimplantation tests.Therefore the conditions of the complaint could not be duplicated by laboratory personnel.A review of the manufacturing records showed no anomalies.The instructions for use that accompanies the device states the following in regards to the testing of the patency of a burr hole valve: place the inlet connector of the valve into sterile isotonic saline.Depress the valve dome.Place a finger over the opening at the end of the outlet connector.Release the depressed dome.If fluid enters the reservoir, the inlet connector and flow control membrane valve are patent.Remove finger from the outlet connector opening.Depress dome.If fluid flows out of the outlet connector, the valve is patent.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.

Manufacturer Narrative

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

• Brand Name: CSF- BURR HOLE SHUNT, 12MM, 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, CA 55432 ; 7635260594
• MDR Report Key: 6447279
• MDR Text Key: 71326675
• Report Number: 2021898-2017-00140
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00643169466357
• UDI-Public: 00643169466357
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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,Followup
• Report Date: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 9040 B
• Device Lot Number: D67591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2014
• 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 Age: 1 MO