MAUDE Adverse Event Report: MEDTRONIC DOMINICANA STRATA®; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	42856
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Headache (1880); Loss of consciousness (2418); Convulsion/Seizure (4406)
Date of Event	04/13/2024
Type of Reportable Event	Serious Injury
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
Medtronic received information regarding an adjustable valve.It was reported that the patient underwent "laparoscopic ventriculoperitoneal shunt repositioning" on (b)(6) 2024.On (b)(6) 2024, the patient complained that the headache worsened, the disturbance of consciousness worsened, they could not open their eyes, and they had convulsions.Review of the head ct compared with the (b)(6) 2024, ct film showed hydrocephalus increased significantly than before; changes occurred after ventricular drainage, and the density of the brain parenchyma around the right frontal lobe drainage tube decreased.It was considered that the hydrocephalus worsened to the point where the patient convulsed, the consciousness changed, and after communicating with the family member, they asked the general surgery department to consult and cooperate with the emergency department immediately to plan a "laparoscopic exploration and repositioning of the abdominal end of the ventriculo-abdominal drainage tube" to check that the original shunt tube and accessories were not smooth.On (b)(6) the patient was transferred to the hospital for treatment.The shunt tube and accessories were replaced.
Additional Manufacturer Narrative
B1 updated.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.
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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: STRATA®
• 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: 19172079
• Report Number: 9612501-2024-01040
• Device Sequence Number: 20678149
• Product Code: JXG
• UDI-Device Identifier: 00763000027254
• UDI-Public: 00763000027254
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2024

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 Expiration Date: 09/18/2025
• Device Model Number: 42856
• Device Catalogue Number: 42856
• Device Lot Number: 0224782900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 04/24/2024; 05/07/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 04/24/2024; 05/08/2024
• Date Device Manufactured: 10/04/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 19 YR
• Patient Sex: Male
• Patient Weight: 80 KG