MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) IPG, 5.3AH, SCS, MEDTRONIC HEADER; Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Model Number	3671
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	01/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the ipg became unable to communicate with external devices.It is unknown whether the device was placed into surgery mode.Troubleshooting has been unable to resolve the issue.As a result, surgical intervention may be undertaken to address the issue.
Additional Manufacturer Narrative
Date of event is estimated.
Additional Manufacturer Narrative
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 incident could not be conclusively determined.
Event or Problem Description
A retrospective review indicates this event is connected to 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.
Additional Manufacturer Narrative
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.

• Brand Name: IPG, 5.3AH, SCS, MEDTRONIC HEADER
• Common Device Name: Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
• 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: 24367104
• Report Number: 3006705815-2026-01021
• Device Sequence Number: 12090999
• Product Code: LGW
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Notification,Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/23/2026

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: 08/17/2025
• Device Model Number: 3671
• Device Catalogue Number: 3671
• Device Lot Number: A000146306
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: 03/09/2026; 04/02/2026; 09/01/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/10/2026; 04/29/2026; 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2023
• 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
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 200 LB