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

Device Problems Inaccurate Flow Rate (1249); Device Operates Differently Than Expected (2913)

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

Event Date 05/19/2017

Event Type  malfunction  

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 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.

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.

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
• 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: 6655430
• MDR Text Key: 78033778
• Report Number: 2021898-2017-00335
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00613994803818
• UDI-Public: 00613994803818
• 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,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2017
• Initial Date FDA Received: 06/20/2017
• Supplement Dates Manufacturer Received: 07/06/2017; 07/06/2017
• Supplement Dates FDA Received: 08/03/2017; 10/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1