MAUDE Adverse Event Report: COVIDIEN LLC STRATA®; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 27819

Device Problems Infusion or Flow Problem (2964); Mechanical Jam (2983)

Patient Problem Coma (2417)

Event Date 01/30/2024

Event Type  Injury  

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.

Event Description

Medtronic received information regarding an adjustable valve.It was reported the patient underwent a ventriculoperitoneal shunt on (b)(6) 2024 due to hydrocephalus caused by cerebral hemorrhage.The gear was adjusted to 1.5 during the implantation.The patient remained in a coma during the postoperative period.A ct scan was taken on january 25, 2024, and no shrinkage of the cerebral ventricle was found.On january 26, 2024, the doctor wanted to try to lower the pressure by one level to 1.0, but found that the valve could not be adjusted.On january 26, 2024, the manufacturer representative (rep) went to try adjust it in the afternoon but could not adjust it either.Later, the rep communicated with the director and the rep brought electronic and manual tools to adjust the pressure on the afternoon of january 28, 2024, but the operations were performed for more than half an hour, it still could not be adjusted.The doctor then tried to puncture the reservoir and inject 2 ml of normal saline into it.The pressure could be adjusted to 1.0, but it was very difficult.They tried to adjust it to 0.5 but failed.A follow-up ct scan on the morning of january 30, 2024 found that the cerebral ventricle had not shrunk, and the patient was in a coma.

Event Description

Additional information received reported that the valve position was at 1.0, and the surgeon stated they would observe this for a period of time.

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.

• Brand Name: STRATA®
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 18624156
• MDR Text Key: 334369478
• Report Number: 9612501-2024-00286
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K042465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27819
• Device Catalogue Number: 27819
• Device Lot Number: 0225422721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• Date Device Manufactured: 11/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Female