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

Catalog Number	42546
Medical Device Problem Codes	Inaccurate Flow Rate (1249); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product testing is in progress.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 or Problem Description
It was reported to medtronic neurosurgery that when the nurse did the routine device test of the valve prior to implant, they found that it was not working.According to the report, the valve was replaced and there was no injury.
Additional Manufacturer Narrative
Additional information received reported the valve would not drain normally.The returned valve was patent and met the requirements for reflux and leak testing.Therefore the conditions of the complaint could not be duplicated by laboratory personnel.However, the valve did not meet the requirements for pressure-flow and preimplantation testing.There was proteinaceous debris observed within the interior and exterior of the valve.The instructions for use 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.¿ a review of the manufacturing records showed no anomalies.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.

• Brand Name: CSF-FLOW CONTROL VALVE, BURR HOLE, 16 MM, HIGH PRESSURE
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6655430
• Report Number: 2021898-2017-00335
• Device Sequence Number: 1306482
• Product Code: JXG
• UDI-Device Identifier: 00613994803818
• UDI-Public: 00613994803818
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2017

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: 10/31/2018
• Device Catalogue Number: 42546
• Device Lot Number: D52756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Initial Date Received by Manufacturer: 05/22/2017
• Supplement Date Received by Manufacturer: 07/06/2017; 07/06/2017
• Initial Report FDA Received Date: 06/20/2017
• Supplement Report FDA Received Date: 08/03/2017; 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1