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

Model Number	42866
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Therapeutic Effects, Unexpected (2099); Confusion/ Disorientation (2553)
Date of Event	01/14/2020
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
It was reported that after implantation of the adjustable valve, awareness of the patient had been started to be disoriented.In order to solve the problem, multiple pressure level adjustments had been done, and the patient had been tracked for a while.It was seen that the ventricles of the patient did not get smaller, and as a result of this, the physician decided that the shunt was not draining cerebrospinal fluid.The device was replaced with a new one.The patient's medical history was mass operated, hydrocephalus, and their status at the time of the report was alive - no injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The returned valve was patent.The valve met the requirements for leakage, valve flux, reflux and siphon control testing.The distal end connector of the valve was not straight and was observed to be slightly bent.The valve did not meet requirements for pressure/flow and pre-implantation testing.It is unknown how this damage and failure may have occurred.The ifu cautions, ¿low tear strength is a characteristic of most silicone elastomer materials.Improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting or crushing of components.Such damage may lead to loss of shunt integrity and necessitate premature surgical revision of the shunt system.¿ dhr review of lot # e62989 did not indicate any defects related to the issue observed in the field.All valves are 100% leak 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 II VALVE, REGULAR
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• MDR Report Key: 9683894
• Report Number: 2021898-2020-00057
• Device Sequence Number: 19618438
• Product Code: JXG
• UDI-Device Identifier: 00643169975835
• UDI-Public: 00643169975835
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K042465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (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): 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 42866
• Device Catalogue Number: 42866
• Device Lot Number: E62989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 03/01/2020; 02/27/2021
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 03/02/2020; 03/19/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 13 YR
• Patient Weight: 40