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

Model Number 42955

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Extreme Exhaustion (1843); Headache (1880); Therapeutic Effects, Unexpected (2099); Visual Disturbances (2140); Ambulation Difficulties (2544)

Event Date 12/07/2016

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 was implant with the device 2 1/2 years ago.It was stated the device had issues from the start.Multiple ct scans showed that the ventricles were always collapsed because way too much fluid was being drained regardless of how the device was set.The patient experienced brutal headaches (worst ice cream freeze ever all the time and only massive amounts of sleep would help it), balance issues (felt like they were on a boat in a storm and severe enough where they felt unsafe to drive), fell a lot, severe pain in the head when coughing and sneezing (felt like they were hit in the head with a baseball bat, and pain would persist, extreme crippling fatigue (would sleep 10-12 hours each night and always sleep through at least one day on the weekend), light sensitivity (could not go outside without sunglasses, and pain when looking at computers or screens), and issues with movies (would usually end up in bed in agony for 1-2 days if we went to the theater).The device also did not respond consistently to the programmer to measure or change the settings.The device was replaced in (b)(6) 2019, and all of the symptoms went away immediately following the replacement.

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, SMALL
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8861733
• MDR Text Key: 153292337
• Report Number: 2021898-2019-00305
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00643169692718
• UDI-Public: 00643169692718
• Combination Product (y/n): N
• PMA/PMN Number: K152700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: 42955
• Device Catalogue Number: 42955
• Device Lot Number: E18556
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2019
• 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
• Patient Age: 45 YR
• Patient Weight: 102