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

Model Number 42955

Device Problem Insufficient Information (3190)

Patient Problems Headache (1880); Memory Loss/Impairment (1958); Cognitive Changes (2551); 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.

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

Additional information received reported that the patient had a history of 3 concussions.2 were due to fall during skiing.The 3rd was on (b)(6) 2015 after falling off a ladder.Since that time, they had slowing been more confused, and their mood had changed.They had had worsening balance and increased urinary incontinence.After experiencing the personality changes and gait ataxia, the patient was diagnosed with communicating hydrocephalus.On (b)(6) 2016, they were implanted with the device in the left lateral ventricle of their brain.After being implanted, the patient experienced trouble focusing and memory loss.These symptoms put them in physical danger after they got lost backpacking, and almost caused them to lose their job because they "weren't all there." the patient reported several doctor visits related to their reoccurring symptoms of hydrocephalus.Specially, they were seen on december 1, 2016, (b)(6) 2016, (b)(6) 2016, (b)(6) 2017, (b)(6) 2017, (b)(6) 2017, and (b)(6) 2017 for shunt-related issues.On (b)(6) 2017, the patient visited the doctor for a shunt evaluation and adjustment.They complained of headach es that were worse than when the valve was set at 0.5 and memory issues over the last 1 month which were similar to their cognitive state prior to surgery.Around (b)(6) 2017, the patient's doctor contacted them to inform them that the device had been recalled and suggested they undergo a revision surgery to remove and replace the device.On (b)(6) 2017, the device was removed and replaced with another device from the manufacturer.

• Brand Name: STRATAMR VALVE, SMALL
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7866175
• MDR Text Key: 119921722
• Report Number: 2021898-2018-00455
• 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: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: 42955
• Device Catalogue Number: 42955
• Device Lot Number: E18555
• 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