MAUDE Adverse Event Report: ABBOTT MEDICAL LIBERTA RECHARGEABLE IPG; DBS IPG

Model Number	62400
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	10/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The date of event is estimated.E1- initial reported phone number: (b)(6).
Event or Problem Description
It was reported that the patient experienced heating at the ipg site.Surgical intervention was undertaken wherein the ipg was explanted and replaced.
Additional Manufacturer Narrative
The reported observation of warm ipg site was not confirmed during electrical analysis of the ipg which included temperature testing with stimulation on at the patient¿s settings.While the ipg was in the thermal chamber with stimulation turned on, the ipg internal thermister temperature and external thermocouple temperature correlated and were within the expected range.A diagnostic log review did not note any anomalies.The device was subjected to a functional test on automated test equipment (ate).This tester verifies the electrical performance of the control/communication circuitry, output signal integrity, all test steps passed.Additionally, the device history record of the device was reviewed to confirm that all manufacturing steps were completed and there were no non-conformance's noted that could have contributed to this issue.

• Brand Name: LIBERTA RECHARGEABLE IPG
• Common Device Name: DBS IPG
• 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: 23469159
• Report Number: 1627487-2025-05400
• Device Sequence Number: 8890964
• Product Code: MHY
• UDI-Device Identifier: 05415067047663
• UDI-Public: (01)05415067047663(10)T00006741(17)270202
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P140009
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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 Model Number: 62400
• Device Catalogue Number: 62400
• Device Lot Number: T00006741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2025
• 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: DBS EXTENSION (X2).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female