MAUDE Adverse Event Report: ABBOTT MEDICAL ABBOTT SCS; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Health Effect - Clinical Codes	Bruise/Contusion (1754); Shock from Patient Lead(s) (3162); Convulsion/Seizure (4406)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reports that in late (b)(6) 2024 she turned off the abbott scs stimulation after developing an "eggplant-sized" bruise along her spine that curved toward her hip and then up her side to her rib cage.Concurrent with the bruising, she experienced frequent convulsions/shocks/spasms.She immediately contacted dr.Office regarding these symptoms, but her call was not returned.A few days later, her pharmacist suggested that the abbott scs stimulation might be causing the bruising and convulsions.She subsequently turned the stimulation off, after which the convulsions stopped immediately and the bruise resolved over the course of approximately one week.The stimulator remained off since that time.

• Brand Name: ABBOTT SCS
• Common Device Name: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 23907358
• Report Number: MW5181298
• Device Sequence Number: 5358647
• Product Code: LGW
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date (Section B): 12/19/2025

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/29/2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Disability
• Patient Sex: Female