MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA NSC VALVE, SMALL; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	42355
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/16/2020
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 the when the valve was going to be implanted, the chamber of the valve would fill, but no liquid would drain from the chamber to the distal connector, and no liquid would come out in the way to the peritoneal catheter.The valve could not be implanted; however, the physician place a straight connector to join the ventricle catheter to the peritoneal catheter to complete the procedure.The event resulted in a 30 minute delay in the procedure.The patient's status at the time of the report was alive-no injury.
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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
Additional information received reported there were no environmental/external/patient factors that may have led or contributed to the issue.
Additional Manufacturer Narrative
The returned valve was patent.The valve passed patency test after applying significant amount of pressure which is otherwise not required.The valve met the requirements for valve flux testing, siphon control, reflux and leakage.The valve did not meet the requirements for pressure/flow and pre-implantation testing.No signs of damage on the valve or debris were observed on the valve.However, the interior film on the base of the valve appeared to be lifted off from the base at the inlet connector side of the valve.This may be a potential cause for preventing flow through the valve resulting in the valve not being patent in the field.It is unknown how this damage may have occurred.Dhr review of lot # e72957 did not indicate any defects related to the issue observed in the field.All valves are 100% tested at the time of manufacture.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: STRATA NSC VALVE, SMALL
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• MDR Report Key: 9973225
• Report Number: 2021898-2020-00123
• Device Sequence Number: 3775982
• Product Code: JXG
• UDI-Device Identifier: 00643169975798
• UDI-Public: 00643169975798
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K033850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2020

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: 09/30/2024
• Device Model Number: 42355
• Device Catalogue Number: 42355
• Device Lot Number: E72957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 04/20/2020; 11/10/2020
• Initial Report FDA Received Date: 04/17/2020
• Supplement Report FDA Received Date: 04/27/2020; 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1