MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) EXTENSION, 60CM; SCS EXTENSION

Model Number	3386
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	07/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient was admitted to the hospital and diagnosed with an infection.The patient's white blood count was high.In turn, the scs system was explanted to address the issue.Patient was also treated for the infection.
Additional Manufacturer Narrative
Date of event is estimated.
Additional Manufacturer Narrative
A patient was admitted to the hospital and diagnosed with an infection was reported to abbott.The patient's white blood count was high.The scs system was explanted to address the issue.The patient was also treated for the infection.As a result, 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: EXTENSION, 60CM
• Common Device Name: SCS EXTENSION
• 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: 22807581
• Report Number: 3006705815-2025-05923
• Device Sequence Number: 9063517
• Product Code: LGW
• UDI-Device Identifier: 05414734402330
• UDI-Public: (01)05414734402330(10)A000160848(17)260725
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 09/23/2025

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: 07/25/2026
• Device Model Number: 3386
• Device Catalogue Number: 3386
• Device Lot Number: A000160848
• 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: 07/19/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 68 KG