MAUDE Adverse Event Report: ABBOTT MEDICAL ETERNA CHARGING SYSTEM; SCS CHARGING SYSTEM

Model Number	36700
Medical Device Problem Codes	Melted (1385); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
It was reported that the patient's ipg charger was burnt.
Additional Manufacturer Narrative
Additional information revealed that the charger was nonfunctional, there was no allegation of melting or burning, therefore this device is no longer reportable.
Event or Problem Description
Additional information revealed that the charger was nonfunctional, there was no allegation of melting or burning.

• Brand Name: ETERNA CHARGING SYSTEM
• Common Device Name: SCS CHARGING SYSTEM
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: sara speyerer ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 23953958
• Report Number: 1627487-2026-00044
• Device Sequence Number: 8953055
• Product Code: LGW
• UDI-Device Identifier: 05415067051905
• UDI-Public: (01)05415067051905(10)10826736(17)270326
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 36700
• Device Catalogue Number: 36700
• Device Lot Number: 10826736
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 01/04/2026
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2025
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCS ANCHORS (X2); SCS IPG; SCS LEADS (X2)
• Patient Sex: Male