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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

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NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Muscle Spasm(s) (1966); Pain (1994)
Event Type  Injury  
Event Description
(b)(6) hospital in (b)(6) used a neuromonitoring device perioperatively on the patient on (b)(6) 2018.Patient was age (b)(6) and she was suffering from pre-existing brain/neck injury from a bus accident.It damaged the patient's brain and spine.It left her severely spastic, debilitated, aware but in severe pain, paralyzed, non-ambulatory, able to move legs a little, but she woke up, unable to stand up from a chair again.She was subjected to tcemep aka tcmep to the brain's motor cortex and train of 4 to the cervical spine.She suffered spasms in surgery from the electrical stimulation requiring the surgeon to cause the perioperative neurologist to complain about repeated neuroblockades in her suspiciously revised (on date of discharge (b)(6) 2018).Patient was unaware she would be subjected to electrical stimulation during operation.She was also subjected to meps to the distals (arms/legs).She woke up with pointy feet like a ballerina.She was never able to get up from a sitting position again.She developed more aggressive, progressive spasticity, globally.It was painful.She was denied baclofen.She was misdiagnosed in order to make her qualified for the elective surgery.The surgical team even sounds doubtful about their venture.On some level, they knew they did her wrong.We later found out they diverted her away from a palliative evaluation.She had a bus accident that led to what seemed to be cauda equina indicators, but her brain injury and neck injury was known to the hospital when it evaluated her on the date of the accident in the er.They have all the baseline spine imaging and a brain mri.Another hospital has the oldest mri from ten years prior to brain stroke.They even took advantage of her by admitting her to the hospital for a questionable brain stroke evaluation of an old brain stroke.It was really disruptive and unnecessary.They also violated her rights during that in-patient encounter by calling for a psych eval in violation of her religious exemption rights in california, which was stopped by the medical group when they were reminded of her religious status.Then they tried to undo that by altering her religious status to legally get away with it.The patient suffered damage to the corticospinal tracts.She also suffered from the area near the brain stem which is also associated to the additional damage done by endotracheal intubation to her degenerated cervical spine from the 2016 accident.She found out late in the process, near when she was hospice-diagnosed, that she could have had a palliative consult, but the surgical team prevented it in a doctor-to-doctor conversation with the medical group.She was misdiagnosed by her neurologists and then he allowed the anesthesiologist and neurosurgeon to misdiagnose her officially to get the elective surgery approved.She knew nothing of this.She was never introduced to the idea that she was becoming paralyzed due to the brain/cervical injury on the bus.That they made it so much worse with the surgical processes.The stimulation during the surgery was so intense that the neurosurgeon was documented requesting more neuroblockades.The anesthesiologist might have broken a needle tip or damage a cortical spinal track during that administration of the paralytic.He also performed unnecessary endotracheal intubation instead of a safer nasal tracheal or fiber optic.The repeated meps damaged her lower leg muscles (bilateral plantar flex, wasting), wrists (carpel tunnel), right rotator cuff injury, neck deformity, levoscoliosis, and a very strange rapid back deformity into severe kyphosis that required a special flex-coil mri table for the cervical/brain scans.Her spasticity was allowed to go untreated and undiagnosed.She suffered and the surgery could have been prevented if they had instead directed her to palliative for management.Alternately, the hospital failed to refer her to (b)(6) or (b)(6).Medical records are available.The patient suffered tremendously.She should not have been subjected to this device during the operation.It damaged her central nervous system.It is a dangerous device that needs to be eliminated from use.It is becoming popular for neurosurgery.We need an investigation.Risk management is not likely to help out at the hospital to give us the name of the device used.The neurosurgeon was being blamed by the neurologist involved in the surgery who wasn't supposed to be there in the first place.Lumbar surgeries do not require tcemep.This patient would never have approved of its use because of the electrical aspect.She had been electrocuted when she was a child and nearly died.Her life was wasted away because of this surgery and the processes involved.She was not allowed to have the actual services she needed, which were spasticity management, baclofen pump to manage her worsening spasticity, palliative and eventually hospice care.She was never given the chance to be treated properly.It was callous, brutal and horrific what was done to her.Her in-network neurologist failed her utterly.He misdiagnosed her after the neurosurgeon and anesthesiologist misdiagnosed her to get that unnecessary elective surgery approved by the medical group.It was fraud and they used this device to make more money.It was ruthless.Fda safety report id# (b)(4).
 
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Brand Name
NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
Type of Device
NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
MDR Report Key10559877
MDR Text Key207944018
Report NumberMW5096765
Device Sequence Number2
Product Code BSP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 09/16/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received09/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age74 YR
Patient Weight57
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