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

Model Number	62400
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	Movement Disorder (4412)
Date of Event	11/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's symptoms returned.The ipg was unable to properly communicate with external devices and displayed a charge discrepancy.Troubleshooting has been unable to resolve the issue.As a result, surgical intervention was undertaken on (b)(6) 2025 wherein the ipg was explanted and replaced to address the issue.
Additional Manufacturer Narrative
Date of event is estimated.
Additional Manufacturer Narrative
During processing of this complaint, attempts were made to obtain complete patient information.The reported observation was confirmed when reviewing the clinician programmer log from the field.The root cause of the reported observation was not ascertained.The device displayed and logged normal battery values during analysis.Review of the lab standard cp/pc logs aligned with the device¿s soc during analysis.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 and charging circuitry.All portions of ate testing passed which includes charge testing of the eterna device.The ate also measured an ipg battery voltage that aligned with the as received cp/pc query of the device¿s soc.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.

• 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: 23851465
• Report Number: 1627487-2025-06264
• Device Sequence Number: 21232376
• Product Code: MHY
• UDI-Device Identifier: 05415067047663
• UDI-Public: (01)05415067047663(10)10232818(17)260223
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/04/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/23/2026
• Device Model Number: 62400
• Device Catalogue Number: 62400
• Device Lot Number: 10232818
• 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: 11/26/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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 BURR HOLE CAP COVERS (X2); DBS EXTENSIONS (X2); DBS LEADS (X2)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male