MAUDE Adverse Event Report: Abbott Medical Proclaim¿ DRG Implantable Pulse Generator; Dorsal Root Ganglion Stimulator For Pain Relief

Model Number	3664
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	08/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced pain at both ipg sites.As a result, surgical intervention was undertaken on both system were explanted to address the issue.
Additional Manufacturer Narrative
Date of event is estimated.

• Brand Name: Proclaim¿ DRG Implantable Pulse Generator
• Common Device Name: Dorsal Root Ganglion Stimulator For Pain Relief
• 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: 50877098
• Report Number: 1627487-2026-10259
• Device Sequence Number: 10715375
• Product Code: PMP
• UDI-Device Identifier: 05415067020215
• UDI-Public: (01)05415067020215(10)T00005403(17)250329
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P150004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/29/2025
• Device Model Number: 3664
• Device Catalogue Number: 3664
• Device Lot Number: T00005403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 09/24/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DRG Lead; DRG Lead
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 200 LB