MAUDE Adverse Event Report: ABBOTT MEDICAL LIBERTA RECHARGEABLE IPG; Stimulator, Electrical, Implanted, For Parkinsonian Tremor

Model Number	62400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chronic Obstructive Pulmonary Disease (COPD) (2237); Respiratory Failure (2484); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient passed away within 30 days of an abbott procedure.The cause of death is unknown.
Additional Manufacturer Narrative
B3: event date is estimated.
Event or Problem Description
Additional information received reports that the patient had copd (chronic obstructive pulmonary disease) prior to their death.
Additional Manufacturer Narrative
A patient death was reported to abbott.Event details describe health issues unrelated to the implanted system.Additionally, no dbs system complaints were reported nor were implanted products returned for analysis.All event information pertaining to this device has been reviewed and no product investigation is necessary at this time as the circumstances of the event have not been attributed to the implanted system.This death is not device or procedure related.A device history record was performed to review and confirm the sterility of devices.

• Brand Name: LIBERTA RECHARGEABLE IPG
• Common Device Name: Stimulator, Electrical, Implanted, For Parkinsonian Tremor
• 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 ; +1(972)309-8000
• MDR Report Key: 24090144
• Report Number: 1627487-2026-00261
• Device Sequence Number: 10341046
• Product Code: MHY
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/25/2026

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 Lot Number: T00007317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 01/20/2026; 05/21/2026; 09/25/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 02/11/2026; 05/26/2026; 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2025
• 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 BURR HOLE COVER (X2).; DBS EXTENSION (X2).; DBS LEAD.
• Outcome Attributed to Adverse Event: Hospitalization; Other; Death
• Patient Sex: Male
• Patient Weight: 175 LB