MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA II SHUNT ASSEMBLY, SMALL, WITH BIOGLIDE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 27818

Device Problem Infusion or Flow Problem (2964)

Patient Problem Vomiting (2144)

Event Date 12/10/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported developed vomiting, jet-like, no fever, without abdominal pain, diarrhea or other discomforts after eating for 1 hour on (b)(6) 2020.There was no improvement after conventional treatment.Considering that the shunt tube was blocked, the patient underwent surgery.It was noted that cerebrospinal fluid did not flow out of the abdominal cavity.The valve was opened and it was squeezed, but the cerebrospinal did not flow out.The whole set of shunt tube was taken out, and a new set of shunt tube was implanted as it was considered that the valve was damaged which was causing the shunt tube malfunctions.

Event Description

Additional information received reported that there were no environmental/external/patient factors that may have led or contributed to the issue.It was noted that the implant date was (b)(6) 2016; however, the specific date was unknown.

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.

Manufacturer Narrative

The device could not be tested due to a broken distal connector on the valve.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 II SHUNT ASSEMBLY, SMALL, WITH BIOGLIDE
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• MDR Report Key: 11037846
• MDR Text Key: 222349221
• Report Number: 2021898-2020-00369
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K042465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2021

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
• Device Operator: Health Professional
• Device Model Number: 27818
• Device Catalogue Number: 27818
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2021
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 12/21/2020; 03/08/2021
• Supplement Dates FDA Received: 12/28/2020; 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 4 YR
• Patient Weight: 10