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

Model Number	44465
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Headache (1880)
Date of Event	01/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received regarding a patient undergoing revision of an lp shunt and insertion of an nsc strata valve.During procedure, the valve was set at 1.5.One week post procedure the patient experienced low pressure headaches, so the setting was increased to 2.0 that day, and to 2.5 two weeks later.There was no change in symptoms at the time.However, on (b)(6) 2021 a revision surgery was performed during which a new valve was inserted, just to check whether the previously valve was malfunctioning.Additional information received from the physician noted that the patient is still showing symptoms, but the new valve is deemed functional.
Additional Manufacturer Narrative
The returned valve was patent.It met the requirements for leakage, reflux, pressure flow and valve flux testing.No unusual characteristics were observed.The laboratory personnel was unable replicate the failure of inadequate flow observed in the field.Dhr review of lot#: e39516 did not show any anomalies associated with the failure of inadequate flow observed in the field.All valves are 100% pressure 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.

• Brand Name: STRATA NSC LP VALVE
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• MDR Report Key: 11317155
• Report Number: 2021898-2021-00041
• Device Sequence Number: 4125584
• Product Code: JXG
• UDI-Device Identifier: 00643169975897
• UDI-Public: 00643169975897
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K091312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

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: 09/30/2022
• Device Model Number: 44465
• Device Catalogue Number: 44465
• Device Lot Number: E39516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention