MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION DEEP BRAIN STIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Model Number 37601

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Memory Loss/Impairment (1958); Disability (2371); Sleep Dysfunction (2517); Cognitive Changes (2551); Movement Disorder (4412); Speech Disorder (4415); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Eye / Vision Problem (4471)

Event Date 04/17/2020

Event Type  Injury  

Event Description

The date i put is my best guess without looking at my dad's records.This following explains in detail my complaint and is what i sent to a law firm which, so far i have been turned down numerous times.At the end i include device numbers.Hello my name is (b)(6), and i am (b)(6) from (b)(6) (very rural place) this is for a: medical device, and medical malpractice case.A) my dad, (b)(6), had a medtronic- deep brain stimulator (dbs)- bilateral removed in (b)(6) 2020.B) my dad suffered severe mental and physical disability.He went from being somewhat independent (able to drive, walk, talk, get groceries) to needing full medical care affected speech, legs, arms, memory, cognitive thinking, eyes, sleep, and sanity (my dad was walking around naked in his apartment building).C) i understand "the discovery rule" would be important in this case as my dad's treatment is over a long period (statute of limitation extended 2 years from date of discovery, with "discovery rule" ((b)(6)) my dad's discovery is (2020) in our case.Regardless, my dad had a second implant in (b)(6) 2015 which falls under (b)(6) device statute law- i am told (7 years) which would make 2022 the limit).And likely dad was seen within 2 years malpractice limit by neurologist who tampered with device- "adjusted settings" (2018-2020).D) discovery of this was made from (b)(6) to present (b)(6) because my dad has improved significantly since the removal and i have proof the device was the issue.For years (2015-2016-to present) the doctors at u of (b)(6) denied our plea for removal, or our complaints, and experimented with my dad.The primary neurologists are in (b)(6), area, and either neglected or continued to experiment with my dad.My dad had the original device placed in 2010 (in (b)(6)) and we were strung along by doctors telling us the dbs would work.Also, this happened in 2015 with the original chest implant ("the brains") being replaced.E) any statute of limitations were not neglected on our part, but for 10 years, and especially the last 5 years, we have been told that dbs was not the problem or to "try a new setting" on the device.F) this has been devastating to my work, and my dad's life g.Dbs itself is known to cause problems according to doctors, a mental side effects- https://www.Ncbi.Nlm.Nih.Gov/pmc/articles/pmc4837159/ b.Physical problems- https://www.Neurologyadvisor.Com/advisor-channels/movement-disorders-advisor/weighing-the-risks-of-deepbrain- stimulation/#:~:text=an%20individual%20who%20has%20undergone,the%20aftermath%20of%20dbs%20surgery.Device #'s for dad's 2 devices (chest implant; "the brains") one in june 2015- model: 37601, serial (b)(4), one in april 2010- model: 7428, serial (b)(4), about the product- there were two devices: i believe the u of (b)(6) took the older device, and i assume sent it to medtronic-model #7428 the second, most recent device, was sent to medtronic as well from what i am told at (b)(6) model # 37601.Fda safety report id # (b)(4).

• Brand Name: DEEP BRAIN STIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 10733347
• MDR Text Key: 213472760
• Report Number: MW5097447
• Device Sequence Number: 2
• Product Code: NHL
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 10/22/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37601
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/23/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 65 YR
• Patient Weight: 70