MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROTÉGÉ MRI IPG; SCS IPG

Model Number	3771
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	03/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: event date is estimated.During processing of this incident, attempts were made to obtain complete patient information.Further information was requested but not received.
Event or Problem Description
It was reported that the patient had pain at the ipg site.Surgical intervention was undertaken and the system was explanted.
Additional Manufacturer Narrative
The protégé ipg was explanted due to discomfort.This event is related to patient factors and cannot be confirmed through product analysis testing.Per event details, the patient had lost a lot of weight and the implant was causing discomfort.There were no allegations of deficiency against the ipg.Visual inspection of the ipg did not identify any anomalies that would contribute to the reported issue.The ipg communicated and charged normally with lab standard equipment.

• Brand Name: PROTÉGÉ MRI IPG
• 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 ; 9723098000
• MDR Report Key: 24854027
• Report Number: 3006705815-2026-02271
• Device Sequence Number: 10549146
• Product Code: LGW
• UDI-Device Identifier: 05415067017086
• UDI-Public: (01)05415067017086(10)A000029699(17)181004
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2026

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: 10/04/2018
• Device Model Number: 3771
• Device Catalogue Number: 3771
• Device Lot Number: A000029699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2026
• 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: 03/18/2026
• Supplement Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 07/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2016
• 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 LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Male