MAUDE Adverse Event Report: Abbott Medical Orion RC SCS IPG

Model Number	32400
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury

• Brand Name: Orion RC SCS IPG
• Common Device Name: SCS IPG
• Manufacturer (Section D): Abbott Medical; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): Abbott Medical; 6901 preston rd; plano TX 75024
• Manufacturer Contact: sara speyerer ; 6901 preston road; plano, TX 75024 ; +1(972)309-8000
• MDR Report Key: 50892226
• Report Number: 1627487-2026-10289
• Device Sequence Number: 5903724
• Product Code: LGW
• UDI-Device Identifier: 05415067040763
• UDI-Public: (01)05415067040763(10)10134256(17)251220
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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 Expiration Date: 12/20/2025
• Device Model Number: 32400
• Device Catalogue Number: 32400
• Device Lot Number: 10134256
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male