MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CARDIAC/PERITONEAL CATHETER, STANDARD, BARIUM IMPREGNATED, 90 CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 43103

Device Problems Disconnection (1171); Fracture (1260)

Patient Problems Visual Impairment (2138); Dizziness (2194); Ambulation Difficulties (2544); Cognitive Changes (2551)

Event Date 05/19/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient received a ventricular-abdominal shunt due to hydrocephalus and recovered well after the operation.On (b)(6) 2021, the patient had sudden dizziness and unsteady walking accompanied by decreased vision.The patient went to the emergency department of the hospital.After they were admitted by the hospital for hospitalization, the symptoms were relieved by infusion of mannitol.The patient's pressure of their shunt was adjusted and reduced as well during the hospitalization which their clinical symptoms improved immediately.After discharge, the symptoms recurred in a short time, and the patient was admitted to the hospital again.After the shunt was adjusted, the patient's symptoms improved within a short time and then worsened again.Ct review was performed, and hydrocephalus worsened and consciousness reaction gradually deteriorated.Ct examination of the head, neck, chest, abdomen, and pelvis revealed that the abdominal cavity end of the shunt was dislocated.Replacement surgery of the ventricle shunt was performed on (b)(6) 2021, and during the operation, it was found that the abdominal end of the shunt was broken.After the replacement of the abdominal end of the shunt, the patient's clinical symptoms improved immediately, and they were discharged in a short time.The patient denied violence and strenuous exercise that could have caused the issue.

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: CARDIAC/PERITONEAL CATHETER, STANDARD, BARIUM IMPREGNATED, 90 CM
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• MDR Report Key: 12129815
• MDR Text Key: 260322416
• Report Number: 2021898-2021-00135
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00643169466821
• UDI-Public: 00643169466821
• Combination Product (y/n): N
• PMA/PMN Number: K792005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: 43103
• Device Catalogue Number: 43103
• Device Lot Number: E12234
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 16 YR
• Patient Weight: 40