MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION MEDTRONIC SYNCHROMED II INTRATHECCAL BACLOFEN PUMP; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-20

Device Problem Nonstandard Device (1420)

Patient Problems Fall (1848); Pain (1994); Convulsion/Seizure (4406)

Event Date 06/15/2020

Event Type  Injury  

Event Description

I have one of the model numbers that was in the class action lawsuit against medtronic but as soon as i came out of this hospital visits, my lawyer dropped me because of what they were saying about the overdosing even though i showed them that clean toxicology report 2016 my doctor wanted to place a medtronic synchromed to baclofen intrathecal pump into my spine to help me walk.He did so knowing that it was already fda recalled as a defective product i just found out all of this.In 2017 i started having seizures grand mal seizures out of nowhere i'd be walking across the room and just drop.I've never had seizures before in my life.I've been having them ever since intermittently.I reported it to my doctor he refuses to speak with me about it at all i started to report it to the hospital and then i noticed that things at the local hospital people were planting stuff in my records that were not true as they say doctors cover each other's "asses." (b)(6) 2020 my dad has just been over my house to help me with my ethernet cord i was starting a dream job the next morning i'm a single disabled mom of a disabled little boy.He's my world my dad asked if he could take my son for the night and i said yes after they left again my pump stalled and i dropped into seizures for 13 hours.I seized on the floor of my apartment with my dinner all over the floor around me.My dad and my son came the next morning knew something was wrong so i wasn't answering the door but my car was there they had to break into the house and found me almost dead.They took me to this local hospital and because i have to have pain medication i had one fentanyl pain patch on it was a 25 microgram patch and then there was one stuck on the inside of my bra i didn't know about it was on my bra though not on my body and the doctor that they called him for consultation, psychologist put down in my records that i was covered in fentanyl patches and then i overdosed on drugs.He then proceeded to tie me down by all force but my ankles and my wrists for four straight days and then he baker acted me from there i had no idea what was going on.I couldn't talk, i couldn't communicate, he was telling everybody that walked by my room that i was a drug addict so are the nurses because they were asking if i needed help, because i couldn't speak for myself they took off my leads and laughed at me and said see she's just a drug addict.I had been telling them about this pump in me, and been trying to get it out but nobody wanted to listen nor did they want to document that, so they pay corrected me when i got out of the hospital.I am in the medical field that's what i do is medical records.I went to get my records and i saw that my talk screen was 100% clean which i knew it was.I hadn't been doing drugs like he said or abusing my medications ever then they look deeper ever since the first seizure in 2017.They were planting things in my records to discredit me saying that i had a mood disorder saying that i was a drug addict.I have a past history from when i was younger i abused, but i've been clean and sober for 12 years.Nevertheless same thing happened two weeks later and when the ambulance came i begged them not to bring me to that hospital i have the name of this doctor and i believe he's getting kickbacks as well for baker acting patients, but he did the same exact thing to me.I went to a different hospital and he was the psychiatrist there too.He did the same exact thing all he did was look at me he didn't even talk to me and he said baker actor again.My son has been taken away from me now and terminated my parental rights and i'm fighting in an appeal to get him back but they refuse to this doctor it refuses to meet with me i've been to the medical records and to the hospital numerous times and he doesn't want to acknowledge it it's ruined my life i've lost everything we lost our home of 12 years and i'm dying on the inside and it's all because of this stupid pump.Because of this i've also been living in excruciating pain as because of the lies and neglect of treating the actual problem.I can no longer receive pain medications that i need to walk and function.It's been over 18 months, but even worse is the pain of them taking away.Kidnapping my only beautiful son.My only reason for living.This has all destroyed me.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC SYNCHROMED II INTRATHECCAL BACLOFEN PUMP
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 15503237
• MDR Text Key: 300909370
• Report Number: MW5112327
• Device Sequence Number: 1
• Product Code: LKK
• 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: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 8637-20
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: BACLOFEN; FENTANYL ; LEVOTHYROXINE 88MCG
• Patient Outcome(s): Hospitalization; Required Intervention; Other; Life Threatening
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White