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

Model Number	62400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported an infection was present at the ipg and lead site.In turn, surgical intervention took place wherein the ipg was explanted to address the issue.Patient was prescribed oral antibiotics.
Additional Manufacturer Narrative
Date of event is estimated.
Additional Manufacturer Narrative
Correction: in the initial b5 report the event should have stated infection at the pocket site only not lead site.
Event or Problem Description
Additional information was received stating the infection has resolved.
Additional Manufacturer Narrative
An event of infection was reported to abbott.It was conveyed that the infection originates at the ipg site, however, no explanted products were returned for analysis.The patient was prescribed oral antibiotics to address the issue.The infection has resolved.As a result, a device history record was performed to review and confirm the sterility of the ipg.Based on the documents reviewed, the source of the infection remains unknown.

• 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: 21900925
• Report Number: 1627487-2025-01950
• Device Sequence Number: 11817582
• Product Code: MHY
• UDI-Device Identifier: 05415067047663
• UDI-Public: (01)05415067047663(10)T00006606(17)261114
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Followup
• Report Date (Section B): 08/15/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 62400
• Device Catalogue Number: 62400
• Device Lot Number: T00006606
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 05/12/2025; 08/13/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 06/02/2025; 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2024
• 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.; DBS EXTENSIONX2.; DBS LEADX2.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 79 KG