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
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that pre-operatively there was no flow through the valve.The cause was unknown.There was no patient involvement and the valve was replaced.
Additional 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 accompanies the device instructs that when performing the patency check: 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.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
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7872800
• Report Number: 2021898-2018-00460
• Device Sequence Number: 19454973
• Product Code: JXG
• UDI-Device Identifier: 00643169466067
• UDI-Public: 00643169466067
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K831678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 42534
• Device Catalogue Number: 42534
• Device Lot Number: E44551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1