MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) IPG, 7.5AH, SCS; SCS IPG

Model Number	3672
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	01/30/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimtated.
Event or Problem Description
It was reported that patient experienced burning sensation at the ipg site, x-ray imaging revealed ipg was flipped in pocket and leads were twisted.As a result, surgical intervention may be undertaken to address the issue.
Additional Manufacturer Narrative
The results of the investigation are inconclusive based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.

• Brand Name: IPG, 7.5AH, SCS
• 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: 24405287
• Report Number: 3006705815-2026-01113
• Device Sequence Number: 12837116
• Product Code: LGW
• UDI-Device Identifier: 05415067046406
• UDI-Public: (01)05415067046406(10)A000158977(17)260610
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/31/2026

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: 06/10/2026
• Device Model Number: 3672
• Device Catalogue Number: 3672
• Device Lot Number: A000158977
• 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: 01/30/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2024
• 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).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 82 KG