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

Model Number	MN10200
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.During processing of this complaint, attempts were made to obtain complete event information and patient¿s weight.Further information was requested but not received.
Event or Problem Description
It was reported that patients system was explanted on an unknown date for an unknown reason.During the explant procedure a portion of the patients lead broke off an remains implanted.As a result, surgical intervention may be undertaken to remove remaining portion of lead.The investigation was unable to determine the lead that is associated with the issue.
Additional Manufacturer Narrative
Correction- first notification date- should be (b)(6) 2025 rather than (b)(6) 2025.Correction- b3 - date of event- should be 21jul2025 rather than 22jul2025.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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: 22800249
• Report Number: 1627487-2025-03977
• Device Sequence Number: 8789441
• Product Code: PMP
• UDI-Device Identifier: 05415067025500
• UDI-Public: (01)05415067025500(10)DB7858(17)190719
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 08/20/2025

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 Expiration Date: 07/19/2019
• Device Model Number: MN10200
• Device Catalogue Number: MN10200
• Device Lot Number: DB7858
• 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: 07/22/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 08/20/2025
• 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 Age: 51 YR
• Patient Sex: Female