MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CSF-FLOW CONTROL VALVE, BURR HOLE, 16MM, MEDIUM PRESSURE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	42544
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	12/05/2018
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 prior to the procedure, the physician found there was a ¿pressure problem.¿ the valve was to be replaced and there was no injury to the patient.
Additional Manufacturer Narrative
The returned valve was patent and met the requirements for reflux and leak testing.However, the valve did not meet the requirements for pressure-flow and preimplantation testing.There was proteinaceous debris on the interior of the valve.The instructions for use cautions, ¿care must be taken to ensure that p articulate contaminants are not introduced into shunt components during preimplantation testing or handling.Introduction of contaminants could result in improper performance (overdrainage or underdrainage) of the shunt system.Particulate matter, which enters the shunt system, may also hold pressure/flow controlling mechanisms open, resulting in overdrainage.¿ all valves are 100% tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported that the physician tested the shunt pressure before implantation, and they couldn't get a normal pressure.

• Brand Name: CSF-FLOW CONTROL VALVE, BURR HOLE, 16MM, 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: 8200292
• Report Number: 2021898-2018-00588
• Device Sequence Number: 2279300
• Product Code: JXG
• UDI-Device Identifier: 00643169466913
• UDI-Public: 00643169466913
• 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,Followup
• Report Date (Section B): 03/25/2019

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: 01/31/2023
• Device Model Number: 42544
• Device Catalogue Number: 42544
• Device Lot Number: E42551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 02/12/2019; 03/20/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 03/06/2019; 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1