MAUDE Adverse Event Report: ABBOTT MEDICAL AXIUM¿ NEUROSTIMULATOR SYSTEM; SCS 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	02/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.Information requested, but not yet received.
Event or Problem Description
It was reported that during a lead revision [related manufacturer report number: 1627487-2024-07533,1627487-2024-07534, 1627487-2024-07535, 1627487-2024-07536] on (b)(6) 2024, the ipg was explanted and replaced due to an unknown reason.No further information is known at this time.
Additional Manufacturer Narrative
Correction: upon review, the issue should not have been submitted as a medical device report (mdr) as the device had met or exceeded 75% expected longevity.There is no alleged stated deficiency or malfunction of the device.This device is no longer considered reportable.
Event or Problem Description
Additional information indicates that the device meets or exceeds 75% expected longevity.There is no alleged stated deficiency or malfunction of the device.

• Brand Name: AXIUM¿ NEUROSTIMULATOR SYSTEM
• Common Device Name: SCS 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 18932882
• Report Number: 1627487-2024-07606
• Device Sequence Number: 13097941
• Product Code: PMP
• UDI-Device Identifier: 05415067025500
• UDI-Public: 05415067025500
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• 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): 05/03/2024

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: 03/28/2019
• Device Model Number: MN10200
• Device Lot Number: DB7331
• 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: 02/23/2024
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 84 KG