MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION MEDTRONIC'S PAIN PUMP; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Patient Problems Memory Loss/Impairment (1958); Pain (1994); Low Oxygen Saturation (2477); Ambulation Difficulties (2544); Convulsion/Seizure (4406); Syncope/Fainting (4411)

Event Date 12/21/2023

Event Type  Injury  

Event Description

Almost dead the paramedics said from 2021-2023 including (b)(6) 2023.This will be the ninth time and patel never called the hospital and the hospital came in my room telling me the doctor did not call them back over 3-4 days!.He said he thought i was taking pain pills which i hadn't, and of course he should know that since he was the doctor prescribing them originally before the pump, my son kept a bottle that i didn't even know about just to show that he prescribed them when he should've not been prescribing them with the pump this time the doctors conferred because they had no clue why i was almost dying with a lack of oxygen every time i drift off and they came in the evening to lower it another 25% and it was lowered last november 50% so that shows the doctor had it 75% too high for my size.I can just imagine him saying well you wanted me to raise it because you were in pain and my comment and my son who really is so distraught and developed severe anxiety disorder because of this and won't even drive, i can imagine him, saying that i wanted it.It was his duty as the doctor.A pain doctor, in fact to take a stand as a doctor, and not raise it under any circumstances based on my body weight and then on top of it, he accuses me of taking pain pills and never calls the hospital back when the doctors are calling him trying to get a hold of him thinking the pump is failing.Excuse me he needs to lose his license and ability to use these.This has ruined me.It's a good thing i'm a therapist and i've been able to know emotionally what's going on with me because now i can barely walk and if it wasn't from my will i should be in a wheelchair to tell you the truth because it's extremely difficult to walk and now i'm crunched over like 150-year-old ! his name is (b)(6), in (b)(6).Talk to my son as well the poor thing he is so traumatized and so am i and now i'm angry because of the pain i'm in, almost being dead and i'm very lucky that i have a strong heart, because my heart stopped working and my sons were told that i was taken for dead or brain dead or and they didn't think i'd make it and to start making plans numerous times because of this doctor not returning hospital calls! he thought i was taking orals.It was his duty and obligation to call the hospitals.I have to look and see if i have one of the faulty pumps but that's another thing he hasn't even called to check.I mention this i looked it up to see if there's been any recalls.Yes i was just in the hospital again last week.Thank god i'm in touch with my body the last two times and knew something was weird.The other times i was passed out for dead and didn't wake up in the hospital for a few days and i don't know any of it.I can't remember and not only hasn't me physically my memory is horrible and i'm now scared i'm gonna get severe alzheimer's because i can't remember anything and in the past i have two masters and i'm highly educated, and with my work as a therapist, i need my memory.I also have had financial hardship because i had planned on going back to work part time and full-time 10 years ago before this all started happening the last few years, but just when i was going back three years ago, now, this all started happening and now the pump has to be removed because it's going to die if it hasn't already.It's horrifying.You need to check on this doctor.He needs to lose his license from malpractice.I will pursue this as well.Oh, and by the way, i've had two seizures because of being on too much medicine.Started when i was 74 and the doctors believe it was from too much medication meaning the morphine i highly suggest making sure the doctors really inform their patients verbally, and personally about all the downfalls that can happen with pump and by the way, i suddenly started having seizures this year which i never had before i'm devastated.Almost dead on floor unconscious 9 times in 2 year.There's too many you'll have to call french hospital and sierra vista in san luis obispo and you can talk to the paramedics that had to show up here with ambulances over and over.He needs to have his license revoked and not sell pumps or be a doctor anymore trying to blame pain medicine on me when he's the pain doctor giving out the prescriptions! seriously.How would you feel? if it was your child and a doctor did this, i will definitely be pursuing this and why didn't i hear about recall even if it wasn't my pump so that i kept informed.Again, it's critically important that you inform your doctors that they need to discuss this verbally and not just hand out a piece of paper.Numerous states the hospital has just had to put something in.Only pain which is now worse than i'm extremely stressed and now my son is deeply anxious and developed anxiety "dis".

• Brand Name: MEDTRONIC'S PAIN PUMP
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 18446885
• MDR Text Key: 332146391
• Report Number: MW5149790
• Device Sequence Number: 1
• Product Code: GZB
• 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: 01/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ASPIRIN .; B COMPLEX .; BBS.; MORPHINE.; MULTIVITAMIN.; THYROID MEDICINE.
• Patient Outcome(s): Disability; Hospitalization; Life Threatening; Other
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 43 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White