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

Model Number	44420
Medical Device Problem Codes	Break (1069); Fracture (1260); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Headache (1880)
Date of Event	11/18/2024
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 a shunt.It was reported the lumboperitoneal shunt was placed on (b)(6) 2024.The notes from the implant stated that the peritoneal catheter was not patent after tunneling to the abdomen wound (no free flow cerebrospinal fluid seen).There was no kinking seen.The abdomen catheter was disconnected from the shunt and was found that all proximal parts were patent.The abdomen catheter was removed from the patient and was replaced with a bactiseal catheter from another manufacturer.The patient then experienced a sudden recurrence of headaches recently with no history of injury or contact sport.X-ray and ct scan found that the lumbar catheter had fractured at the l3/4 inside the interspinous space.The damaged shunt was replaced and replaced with a new set on (b)(6) 2024.The patient's status at the time of the report was alive-no injury.
Additional Manufacturer Narrative
H3.Product analysis determined that there was damage observed to the ends of the catheter.It was unknown how or when this damage occurred.Due to the damage to the catheter, the catheter could not be tested for leak or patency testing.Proteinaceous debris was observed on the exterior and interior of the catheter.Due to the amount of proteinaceous debris, testing could not be performed on the valve.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: 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: justin ellis ; 4620 n. beach st.; fort worth, TX 76137 ; 7635265677
• MDR Report Key: 20744713
• Report Number: 9612501-2024-02953
• Device Sequence Number: 8755953
• Product Code: JXG
• UDI-Device Identifier: 00763000027537
• UDI-Public: 00763000027537
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K091312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2025

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: 44420
• Device Catalogue Number: 44420
• Device Lot Number: 0227629460
• 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: 11/20/2024
• Supplement Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2023
• 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; Hospitalization
• Patient Sex: Female