SPINAL CORD STIMULATOR
Received Aug 16, 2022 · Event occurred Jul 1, 2001
Report MW5111524 · MDR key 15242372
Device
Generic name
Stimulator, Spinal-cord, Implanted (pain Relief)
Manufacturer
Medtronic NeuromodulationProduct problems
- Therapeutic or Diagnostic Output Failure
Patient
62 YR · Female
- Arrhythmia
- Headache
- Failure of Implant
- Itching Sensation
- Memory Loss/Impairment
- Tinnitus
- Blurred Vision
- Twitching
- Myalgia
- Inadequate Pain Relief
- Irritability
- Tooth Fracture
- Sleep Dysfunction
- Cognitive Changes
- Eye Pain
- Swelling/ Edema
- Arrhythmia
- Headache
- Failure of Implant
- Itching Sensation
- Memory Loss/Impairment
- Tinnitus
- Blurred Vision
- Twitching
- Myalgia
- Inadequate Pain Relief
- Irritability
- Tooth Fracture
- Sleep Dysfunction
- Cognitive Changes
- Eye Pain
- Swelling/ Edema
Narrative
Description of Event or Problem
OVER THE PAST 22 YEARS, I'VE BEEN PRESCRIBED NEURONTIN FOR NERVE PAIN AT VARIOUS DOSAGES AND VARIOUS TIMES FOR REFLEX SYMPATHETIC DYSTROPHY. MOST RECENTLY IT WAS PRESCRIBED (1200 MG/DAY) TO HELP WITH PRESCRIBED (AND NOT ABUSED) FENTANYL PATCH WITHDRAWAL AND REMOVAL OF A MEDTRONIC SPINAL CORD STIMULATOR WHICH WOULD NOT FUNCTION CORRECTLY, CAUSING MORE PAIN. OVER THE PAST FIVE YEARS, I HAVE WEANED MYSELF OFF OF BOTH NEURONTIN AND THE FENTANYL PATCHES BECAUSE I EXPERIENCE BRAIN FOG, DENTAL ISSUES (CRACKING, BREAKING, EXTRACTION), MEMORY LOSS, EXTREME BLURRY VISION, SWOLLEN LEGS, AND LITTLE PAIN RELIEF. THE WITHDRAWAL SYMPTOMS WERE AWFUL--INSOMNIA FOR DAYS AND DAYS, BLURRY VISION, EYE PAIN, AGITATION, HEADACHES, MUSCLE ACHES, ITCHY/CRAWLING SKIN SENSATIONS, TINNITUS, MEMORY LOSS, HEART PALPITATIONS, SWOLLEN LEGS, AND RESTLESS LIMBS. FDA SAFETY REPORT ID# (B)(4).