MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATAMR VALVE, REGULAR; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 42965

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Headache (1880); Nausea (1970); Therapeutic Effects, Unexpected (2099); Blurred Vision (2137); Vomiting (2144); Dizziness (2194); No Known Impact Or Consequence To Patient (2692)

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 had retained counsel who alleged a revision of the shunt was required.

Event Description

Additional information received reported in august 2016, the patient was suffering from intracranial hypertension.On (b)(6), 2016, they were implanted with the shunt and set at 1.5.The patient experienced headaches from their condition and was occasionally seen in the emergency room over the next 2 years.In (b)(6) 2018, they began seeing a new neurologist.The patient was hospitalized several times over the upcoming months due to increasing symptoms and apparent problems with their device.On (b)(6), 2018, the neurologist made multiple attempts to reset the shunt with different device and could not change the settings.It was stated that the shunt setting persistently gave readings between 1.5 and 2.0, and it did not show that it definitely changed out of the 1.5 or 2.0 settings after attempts were made with 2 different devices to change it.It was noted that the patient had a recent lumbar puncture showing an open pressure of 21.The neurologist asked them to come back when a manufacturer representative could be available to evaluate the shunt.They saw them the following day and their shunt was adjusted to 1.0.The shunt adjustment was not successful and within 2 weeks, on (b)(6), 2018, the patient presented at the hospital with a headache and intermittent nausea/vomiting.It was noted that in the last 4-5 days, the vomiting had become more persistent, and they reported ongoing headache, dizziness, and blurred vision.It was stated the signs and symptoms appeared to be negative pressure headaches consistent with likely overdrainage of the valve.A head ct was performed and showed that it was overdraining as they had slit ventricles.On (b)(6), 2018, the patient's shunt was removed, and they were discharged without complication on the same day.It was stated postoperatively, the patient was eating within a few hours after surgery.They denied any headache, nausea or vomiting.

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: STRATAMR VALVE, REGULAR
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7869582
• MDR Text Key: 119993634
• Report Number: 2021898-2018-00458
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K152700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: 42965
• Device Catalogue Number: 42965
• Device Lot Number: E12265
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1702-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention