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

Model Number 42965

Device Problems Nonstandard Device (1420); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Headache (1880); Blurred Vision (2137)

Event Date 05/16/2022

Event Type  Injury  

Event 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
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY
• MDR Report Key: 14494916
• MDR Text Key: 292961824
• Report Number: MW5109894
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00643169692701
• UDI-Public: (01)00643169692701(17)190531(10)
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 42965
• Device Lot Number: E12952
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: 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
• Patient Outcome(s): Hospitalization
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White