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

Model Number UNKNOWN-S

Device Problem Mechanics Altered (2984)

Patient Problems Intracranial Hemorrhage (1891); Convulsion/Seizure (4406)

Event Date 12/27/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that the patient received their valve in (b)(6) 2020.It was set to 1.0.One month later, it was checked and showed it was still set at 1.0.On (b)(6) 2020, the patient began exhibiting odd behavior.911 was called, and the patient was transported to the hospital.They performed a preliminary test and found that the valve was set at 0.5.Patient was not around any magnets and was at home.It was said that the setting spontaneously changed.The patient ended up with a bilateral brain bleed in which the brain pulled from the skull allowing spinal fluid to seep in.12 hours after admission, they started to have seizures.On (b)(6) 2021, the patient died in the hospital.It was noted that a physician assistant was assigned to monitor and review their case daily after hospital admission.

Event Description

Additional information received reported that the patient began having behavior that prompted the family member to be concerned about shunt failure.It was unknown exactly how long the problem had existed, but once the patient was hospitalized, the family member was told the shunt had not failed in the traditional sense (no blockage).However, what was discovered was that the setting had spontaneously changed from 1.0 to 0.5.It was stated that the patient had been isolated during covid-19, and the family member could not figure out what might have caused a shunt setting change other than a defect or device failure.As a result of the setting change, the patient experienced a brain bleed (bilateral) due to the shunt over draining so it was suspected it may have been like that awhile.The patient was having seizures within 12 hours of being at the hospital.The shunt was adjusted to 2.0 to allow fluid to rebuild.The patient never made it home, they went unresponsive in the hospital, and died.

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: UNKNOWN STRATA VALVE/SHUNT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• MDR Report Key: 11822710
• MDR Text Key: 250543441
• Report Number: 2021898-2021-00112
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-S
• Device Catalogue Number: UNKNOWN-S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death