MAUDE Adverse Event Report: ABBOTT MEDICAL AXIUM¿ NEUROSTIMULATOR SYSTEM; DRG IPG

Model Number	MN10200
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient is scheduled for replacement of their ipg.It is unknown why the ipg is planned to be replaced.As a result, surgical intervention may be undertaken.
Additional Manufacturer Narrative
Date of event is estimated.
Additional Manufacturer Narrative
Correction: this device meets or exceeds 75% of its expected longevity; therefore, it is no longer considered reportable.
Event or Problem Description
Additional information indicates the device meets or exceeds at least 75% of its expected longevity.This device is no longer considered reportable.

• Brand Name: AXIUM¿ NEUROSTIMULATOR SYSTEM
• Common Device Name: DRG 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: 23440988
• Report Number: 1627487-2025-05386
• Device Sequence Number: 8626060
• Product Code: PMP
• UDI-Device Identifier: 05415067025500
• UDI-Public: (01)05415067025500(10)DB6242(17)171008
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P150004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 01/07/2026

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 Expiration Date: 10/08/2017
• Device Model Number: MN10200
• Device Catalogue Number: MN10200
• Device Lot Number: DB6242
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: DRG LEAD (X2)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male