MAUDE Adverse Event Report: Abbott Medical Proclaim¿ 5 Elite Implantable Pulse Generator; Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Model Number	3660
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient developed an infection.As a result, the scs system was surgically removed.Date of explant is unknown.Patient has now completely recovered.
Additional Manufacturer Narrative
Date of event is estimated.Date of explant is unknown.

• Brand Name: Proclaim¿ 5 Elite Implantable Pulse Generator
• Common Device Name: Stimulator, Spinal-Cord, Totally Implanted 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: 50260376
• Report Number: 1627487-2026-09547
• Device Sequence Number: 9863107
• Product Code: LGW
• UDI-Device Identifier: 05415067020192
• UDI-Public: (01)05415067020192(10)6099456(17)190816
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 09/10/2026

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: 08/16/2019
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: 6099456
• 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: 07/21/2026
• Supplement Date Received by Manufacturer: 08/30/2026
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2017
• 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: SCS ANCHOR x 2; SCS LEAD x 2
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 200 LB