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	Wireless Communication Problem (3283)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	09/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following an unrelated surgical procedure wherein the device was not placed into surgery mode, the ipg became unable to communicate with external devices.As a result, surgical intervention was undertaken wherein the ipg was explanted and replaced to address the issue.
Additional Manufacturer Narrative
Date of event is estimated.The device is included in the neuromodulation implantable pulse generator (ipg) proclaim¿ scs family, proclaim¿ drg therapy and infinity¿ dbs systems surgery mode advisory notice issued by abbott on (b)(6) 2026.A patient's ipg stopped communicating/ is inoperable was reported to abbott.The patient underwent an unrelated surgery where the patient's ipg was not placed into surgery mode.As a result, the patient¿s ipg was explanted and replaced.Therapy was restored.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.

• 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: 50913701
• Report Number: 3006705815-2026-06078
• Device Sequence Number: 20271940
• Product Code: LGW
• UDI-Device Identifier: 05415067046383
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Remedial Action: Other,Notification,Recall
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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 Model Number: 3670
• Device Catalogue Number: 3670
• Device Lot Number: A000178923
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1627487-04/02/26-001-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCS Lead.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 250 LB