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

Model Number	42965
Health Effect - Clinical Codes	Headache (1880); Blurred Vision (2137)
Date of Event	05/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
I had the strata mr vp shunt implanted on (b)(6) 2016.Two months later, the mr recall letter went out - the mr was adjusted from 2.0 to 0.5 within 6 months.In 2020, i had a ct of my sinuses whereby the ent saw a pocket of fluid and sent me to (b)(6) neurosurgeon (b)(6).Dr.(b)(6) determined the shunt was overdraining, and set the valve to 1.5.Fast-forward two years, and i started having headaches and blurry vision again.Newest ct scans showed my ventricles considerably larger than they were in the 2020 scans.I stayed overnight in the er at (b)(6) on (b)(6) they first adjusted my shunt down to 0.5 again, then in the morning, set it to 1.0.A month later, the shunt setting was fluctuating between 1.0 and 1.5.Dr.(b)(6) did an exploratory surgery and determined the strata mr to be completely non-functional.On monday, (b)(6), he replaced the strata mr with a strata ii valve.Fda safety report id # (b)(4).

• Brand Name: STRATAMR ADJUSTABLE PRESSURE VALVE
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY
• MDR Report Key: 14494916
• Report Number: MW5109894
• Device Sequence Number: 6018481
• Product Code: JXG
• UDI-Device Identifier: 00643169692701
• UDI-Public: (01)00643169692701(17)190531(10)
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 05/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 42965
• Device Lot Number: E12952
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 300MG GABAPENTIN - 3X DAILY; BENADRYL; CALCIUM; FISH OIL; FLEXERIL - 5MG DAILY; GLUCOSAMINE CHONDROITIN; LIPITOR - 40MG DAILY; LISINOPRIL 20MG DAILY; NORVASC - 5MG DAILY; ONE-A-DAY WOMEN'S; PROZAC - 10MG DAILY; STRATA II ADJUSTABLE PRESSURE VALVE
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White