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

Model Number	MN10200
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event date is estimated.
Event or Problem Description
It was reported that the patient underwent a explant for a unknown reason.No other information is provided.
Additional Manufacturer Narrative
The axium ins was explanted for unknown reasons.There is insufficient information with regards to any allegations against the ipg.The axium ins successfully communicated with lab standard equipment.X-ray analysis revealed a lead terminal end contact (non-functioning) was stuck in the header chamber for ports 1, 2, 3 and 4.The detached lead terminal end contacts likely occurred during the explant procedure.Further electrical tests could not be performed due to the terminal end lead contacts being stuck in all 4 ipg header ports.

• Brand Name: AXIUM¿ NEUROSTIMULATOR SYSTEM
• Common Device Name: DRG INS
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 16386380
• Report Number: 1627487-2023-00738
• Device Sequence Number: 20212480
• Product Code: PMP
• UDI-Device Identifier: 05415067025500
• UDI-Public: 05415067025500
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P150004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2023

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: 04/01/2018
• Device Model Number: MN10200
• Device Catalogue Number: MN10200
• Device Lot Number: DB4787
• 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: 01/17/2023
• Supplement Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 (X4).; DRG LEAD EXTENSION.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male