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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTELLIS SPINAL CORD STIMULATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN
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MEDTRONIC NEUROMODULATION INTELLIS SPINAL CORD STIMULATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN Back to Search Results
Model Number 97715
Health Effect - Clinical Codes Arrhythmia (1721); Headache (1880); Device Overstimulation of Tissue (1991); Paralysis (1997); Scar Tissue (2060); Burning Sensation (2146); Cognitive Changes (2551)
Date of Event 04/19/2024
Type of Reportable Event Serious Injury
Event or Problem Description
The reporter called regarding intellis spinal cord stimulator by manufacturer medtronic.The reporter mentioned he had the device implanted on (b)(6) 2024 for the degenerative disc disease which caused pain.Soon after the device implant, the caller experienced adverse event such as over stimulation, burning sensation, paralysis, heart palpitation, cognitive changes, headaches, scar tissues and lesions formation.The caller also mentioned delay in treatment, improper programming and class 2 recall of the device.
 
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Brand Name
INTELLIS SPINAL CORD STIMULATOR
Common Device Name
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
MDR Report Key21458397
Report NumberMW5166773
Device Sequence Number16878872
Product Code LGW
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2024
Device Explanted Year2025
Reporter Type Voluntary
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 02/24/2025
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number97715
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date02/25/2025
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age44 YR
Patient SexMale
Patient Weight91 KG
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