MAUDE Adverse Event Report: St. Jude Medical - Neuromodulation (Puerto Rico, LLC) Proclaim Plus Implantable Pulse Generator; SCS IPG

Model Number	3670
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient experienced an infection at an unknown site.As a result, surgical intervention was undertaken in (b)(6) 2026 wherein the entire system was explanted to address the issue.
Additional Manufacturer Narrative
Date of event and explant date is estimated.During processing of this complaint, attempts were made to obtain complete event and patient information.A device history record was performed to review and confirm the sterility of devices.Based on the documents reviewed, the source of the infection remains unknown.

• Brand Name: Proclaim Plus Implantable Pulse Generator
• Common Device Name: SCS IPG
• Manufacturer (Section D): St. Jude Medical - Neuromodulation (Puerto Rico, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer (Section G): St. Jude Medical - Neuromodulation (Puerto Rico, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer Contact: sara speyerer ; 6901 preston road; plano, TX 75024 ; +1(972)309-8000
• MDR Report Key: 50859982
• Report Number: 3006705815-2026-05952
• Device Sequence Number: 10026568
• Product Code: LGW
• UDI-Device Identifier: 05415067046383
• 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: 2026
• 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
• Report Date (Section B): 09/22/2026

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 Model Number: 3670
• Device Catalogue Number: 3670
• Device Lot Number: A000183980
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/11/2026
• 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 (x2); SCS LEAD (x2)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female