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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Arrhythmia (1721); Headache (1880); Failure of Implant (1924); Itching Sensation (1943); Memory Loss/Impairment (1958); Tinnitus (2103); Blurred Vision (2137); Twitching (2172); Myalgia (2238); Inadequate Pain Relief (2388); Irritability (2421); Tooth Fracture (2428); Sleep Dysfunction (2517); Cognitive Changes (2551); Eye Pain (4467); Swelling/ Edema (4577)

Event Date 07/01/2001

Event Type  Injury  

Event Description

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).

• Brand Name: SPINAL CORD STIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 15242372
• MDR Text Key: 298202187
• Report Number: MW5111524
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ESTRADIOL1MG/DAY; FENTANYL ; NEURONTIN
• Patient Outcome(s): Disability
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White