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

Model Number	42866
Medical Device Problem Codes	Break (1069); Fracture (1260); Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Headache (1880); Loss of consciousness (2418); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	01/02/2024
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information regarding an adjustable shunt.It was reported that on (b)(6), 2017, the patient was admitted to the hospital due to coma.Examination revealed hydrocephalus.After follow-up, the patient was admitted to the hospital and underwent v-p (ventriculoperitoneal) shunt surgery.On (b)(6) 2024, the patient suddenly had convulsions on the left limbs, accompanied by headaches, and went to a local hospital for treatment.The details were unknown.Later, the above symptoms recurred, accompanied by a brief loss of consciousness.Head ct scan showed: right ventricle enlargement.Head mr scan showed: right lateral ventricle expansion and hydrops, right lateral ventricle top localized protrusion.Diverticulum to be examined.Around (b)(6) 2024, the patient developed a subcutaneous mass on the right side of the neck; no fever, headache, nausea, vomiting, etc.For further diagnosis and treatment, the patient came to our hospital for a follow-up examination on (b)(6) 2024.The head ct scan showed that the right ventricle of the brain had changed after drainage surgery, and compared with the ct scan on (b)(6) 2018, the ct was similar.The patient was hospitalized on (b)(6) 2024.On (b)(6) 2024, the operation was performed.After the patient was under general anesthesia, loosen the hub of the peritoneal drainage catheter of the shunt pump, and pulled out from under the neck incision and put on the line for backup use.After subcutaneous incision of the neck, clear cerebrospinal fluid was found to be flowing out.The broken end of the shunt was located below the tumor.After the original surgical incision of the right rectus abdominis was opened, no shunt stump was found.Intraoperative c-arm radiographs showed no obvious shunt shadow in the abdominal cavity.After reinserting the cervical-abdominal cerebrospinal fluid drainage tube, intraoperative b-ultrasound confirmed again that no shunt stump was found.After multiple explorations, the patient was informed that the patient was aware of the problem of the broken drainage tube.The patient was asked to have a follow-up examination, and the abdominal cavity was evaluated and the drainage tube stump was removed after the follow-up examination on (b)(6) 2024.

• Brand Name: STRATA®
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 19482910
• Report Number: 2021898-2024-00086
• Device Sequence Number: 7976846
• Product Code: JXG
• UDI-Device Identifier: 00613994804648
• UDI-Public: 00613994804648
• 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
• Report Date (Section B): 06/06/2024

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: 07/31/2019
• Device Model Number: 42866
• Device Catalogue Number: 42866
• Device Lot Number: E16470
• 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: 06/05/2024
• Initial Report FDA Received Date: 06/07/2024
• Date Device Manufactured: 09/22/2016
• 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 Age: 27 YR
• Patient Sex: Unknown