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

Model Number	62400
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); Movement Disorder (4412)
Date of Event	07/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's therapy was turning off and on.Surgical intervention was undertaken and the ipg was explanted and replaced.
Additional Manufacturer Narrative
B3: event date is estimated.
Additional Manufacturer Narrative
The reported observation of ipg stimulation being ineffective was not confirmed.The root cause of the observation was not ascertained.The device was subjected to a functional test on automated test equipment (ate).This tester verifies the electrical performance of the control/communication circuitry and output signal integrity and all test steps passed.

• 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: 23019975
• Report Number: 1627487-2025-04499
• Device Sequence Number: 21219053
• Product Code: MHY
• UDI-Device Identifier: 05415067047663
• UDI-Public: (01)05415067047663(10)10642933(17)261015
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 62400
• Device Lot Number: 10642933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2025
• 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: 08/22/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2024
• 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: DBS EXTENSION (X2).; DBS LEAD (X2).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Sex: Female