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

Model Number 42965

Device Problems Mechanical Jam (2983); Mechanics Altered (2984)

Patient Problems Fall (1848); Headache (1880); Nausea (1970); Dizziness (2194); Dysphasia (2195); Numbness (2415); Ambulation Difficulties (2544)

Event Date 07/28/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported the patient was implanted with the device on (b)(6) 2017.On (b)(6) 2017, the patient had a follow up ct scan.The shunt catheter was perfect, and the shunt pumps and fills well.The setting was between 2.0 and 1.5, and the doctor tried to adjust it 6 times to center on 1.5, but it did not move.The patient was having some nausea and headaches.When the doctor palpated the shunt, they were not able to feel the catheter at the connection with the valve.They would have to get an x-ray to see if there was a disconnection.A ct scan was performed, and the doctor could follow the catheter, and they felt it was not disconnected.The patient had fallen on their head multiple times and struck that area.They were having headaches and balance problem, and they were also doing well after surgery and almost back to normal, and then they smacked their head.The patient had smacked their head on a towel rack, on a refrigerator door, and on the inside frame of their car.They had hit their head in the same place multiple times.On (b)(6) 2018, the patient had a follow up appointment where the patient had numerous falls since they were seen in (b)(6).The patient had hit their head at least 12 times.Despite all of this, they subsequently got along until a few days prior when they started to have some increased numbness of their right leg and arm.The patient became more debilitated and needed more assistance.Subsequently, they were brought to the emergency room and then transferred to a hospital.Ct scan done at the emergency room and ct scan done at the hospital both showed very mild ventricular enlargement, but no evidence of obvious shunt malfunction.X-rays of the patient's skull area were done, and there were no evidence of disconnection of the shunt.It was stated the patient had a strange behavioral tendency.When the doctor touched their shunt, they acted like they were fainting, but they did awaken and followed commands.The patient had a history of bipolar disorder and some psychiatric issues.The shunt pumped and filled well.There was no evidence of proximal or distal obstruction.The doctor reviewed the ct and mri previously done, and the shunt setting was at 2.0, so the doctor changed the setting to 1.0, hoping to decrease their ventricular size and perhaps help with some of their headaches.There was no evidence whatsoever that their shunt was malfunctioning.On (b)(6) 2018, the patient went to the emergency room due to pressure and pain in their head, making their motor skills decrease.The patient had been having back issues, and they had a mri of their back.It was stated their shunt was not adjusted after the mri.Since the mri, the patient had felt increasing pressure to the head.Sometimes they felt dizzy and felt like their balance, gait, and coordination was off.At times, their speech was slurred also.Ct scan was performed showing mild hydrocephalus.It was stated their setting was supposed to be at 1.5; however, the doctor stated it was not set at the correct level.The doctor readjusted the shunt, and the patient stated they did feel more comfortable after the adjustment.On (b)(6) 2018, the patient had another follow up appointment due to having issues over the past couple of weeks, recurrence of their symptoms similar to that of when they had a shunt failure.The doctor attempted to dial their shunt but was unable to move it.It was at 1.5 setting.Since the doctor realized it was the shunt that was recalled, he recommended a shunt revision.On (b)(6) 2018, the device was explanted and replaced with another device.

Event Description

Additional information received reported that since their shunt replacement, the patient had no ongoing concerns with their shunt or significant hydrocephalus symptoms.

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: 8926295
• MDR Text Key: 156396542
• Report Number: 2021898-2019-00319
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00643169692701
• UDI-Public: 00643169692701
• 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: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: 42965
• Device Catalogue Number: 42965
• Device Lot Number: E12266
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/10/2019
• 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: 40 YR
• Patient Weight: 52