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

Model Number 42955

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

Patient Problems Fever (1858); Headache (1880); Hearing Impairment (1881); Nausea (1970); Pain (1994); Swelling (2091); Therapeutic Effects, Unexpected (2099); Visual Impairment (2138); Visual Disturbances (2140); Dizziness (2194); Neck Stiffness (2434); Ambulation Difficulties (2544); 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

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

Event Description

Additional information received reported that the patient was diagnosed with intracranial hypertension in (b)(6) 2016.Their doctors tried stenting to relieve their symptoms, but they developed stenosis along with headaches and vision issues.On (b)(6) 2016, they presented for the implantation of a ventriculoperitioneal (vp) shunt, and the shunt was set to 1.0.Following the implant, the patient suffered chronic headaches.They were seen on (b)(6) 2016 and reported ongoing headaches and light sensitivity.At that visit, their physician adjusted their shunt settings to 0,5.The patient was seen 2 weeks later on (b)(6) 2016 reporting ongoing headaches and continued light and sound sensitivity.The patient stated the most concerning issue was the onset of nausea described as motion sickness all the time.They had used over-the-counter medication for motion sickness without improvement in the symptom.They had not tried any tylenol or ibuprofen for the headache pain which they did not feel was greatly improved since changing the shunt setting.The patient had a head ct which did not reveal any significant change in the ventricle size.They did feel like the setting change from 1.0 down to 0.5 made them feel worse.Their shunt was adjusted again back to 1.0.Within 2 weeks, the patient reported to the emergency room on (b)(6) 2017 reporting significant headache and nausea.It was stated the patient reported sudden onset of acute chronic severe right-frontal headache that was exacerbated by bending forward as well as diffuse facial pain and cloudy vision.The patient took hydrocondone and flexieril with no relief.They additionally endorsed nausea, neck stiffness, intermittent fever (100.2), lack of balance, eye pain, diplopia, lightheaded, and baseline leg swelling.They were admitted to the hospital.On (b)(6) 2017, their doctors did a shunt tap as they feared a shunt malfunction.They were discharged from the hospital on (b)(6) 2017.On (b)(6) 2017, the patient saw the doctor to discuss revision of their shunt due to the recall.On (b)(6) 2017, they were admitted for their shunt revision, and they were discharged on (b)(6) 2017.

• 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
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 7865908
• MDR Text Key: 119875317
• Report Number: 2021898-2018-00453
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/10/2019

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
• Date Device Manufactured: 10/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: Z-1702-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention