MAUDE Adverse Event Report: MEDTRONIC, INC. SPINAL CORD STIMULATION (SCS)SYSTEM; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
We were informed on (b)(6) 2024 about an event regarding a patient with medtronic spinal cord stimulation (scs) system.The patient will undergo a procedure to explant the system due to infection.The physician's name is (b)(6).Disclaimer statement: this report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SPINAL CORD STIMULATION (SCS)SYSTEM
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 20524185
• Report Number: MW5161542
• Device Sequence Number: 7340017
• Product Code: LGW
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/01/2024

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?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/23/2024
• Patient Sequence Number: 1
• Patient Sex: Unknown