MAUDE Adverse Event Report: MEDTRONIC DOMINICANA DELTA VALVE, SMALL, PERFORMANCE LEVEL 1.0; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	42812
Medical Device Problem Codes	Infusion or Flow Problem (2964); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Headache (1880); Insufficient Information (4580)
Date of Event	12/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information regarding a valve.It was reported that the patient was experiencing symptoms.The valve was replaced.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.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information received reported that the patient underwent shunt placement back in (b)(6) 2023 and did very well for about 2 month but then subsequently had a valve malfunction for which they underwent valve replacement and then developed what the doctor figured were low-pressure headaches.The patient came in for diagnostic testing in the fall and early winter of 2023 with a working shunt.However, they had severe headaches and underwent placement of a right external ventricular drain at that time.Despite their ventricles being on the plumper side, their intracranial pressures at that time were low, and they did better with the external ventricular drain set at a higher setting and an abdominal binder.Thus, the patient was taken in the winter for a valve replacement in which their valve with pressure level 1.0 was changed out to a valve with a pressure level 1.5.
Additional Manufacturer Narrative
H3.Product analysis determined that the returned device was patent.The valve passed requirements for reflux, leakage and pressure flow/preimplantation testing.No signs of damage or debris were observed on/inside the valve.The distal end of the connector appeared bent, but it did not lead to any failure in flow through the valve or other characteristics tested.The laboratory personnel could not replicate the failure condition of obstruction as observed in the field.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: DELTA VALVE, SMALL, PERFORMANCE LEVEL 1.0
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer (Section G): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 18485908
• Report Number: 9612501-2024-00110
• Device Sequence Number: 9133920
• Product Code: JXG
• UDI-Device Identifier: 00763000028374
• UDI-Public: 00763000028374
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K902783
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2024

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 Model Number: 42812
• Device Catalogue Number: 42812
• Device Lot Number: 0223355058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2024
• Supplement Date Received by Manufacturer: 03/13/2024; 03/22/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 03/20/2024; 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown