MAUDE Adverse Event Report: Abbott Medical Kit Implantable Slim Tip Lead, 50cm; Dorsal Root Ganglion Stimulator For Pain Relief

Model Number	MN10450-50A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	08/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced ineffective therapy.X-ray imaging revealed migration of two leads.As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the left l4-l5 was explanted, and surgical intervention was undertaken on (b)(6) 2026 wherein the left l3-l4 was explanted and replaced to address the issue.It is unknown which leads migrated.
Additional Manufacturer Narrative
Date of event is estimated.Additional components potentially involved in the event include: common device name: kit implantable slim tip lead, 90cm, model: mn10450-90a, udi: (b)(4), serial: (b)(6), batch: 6474140.Common device name: kit implantable slim tip lead, 90cm, model: mn10450-90a, udi: (b)(4), serial: (b)(6), batch: 6474140.

• Brand Name: Kit Implantable Slim Tip Lead, 50cm
• Common Device Name: Dorsal Root Ganglion Stimulator For Pain Relief
• 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 ; +1(972)309-8000
• MDR Report Key: 50923567
• Report Number: 1627487-2026-10331
• Device Sequence Number: 5778842
• Product Code: PMP
• UDI-Device Identifier: 05415067025531
• UDI-Public: (01)05415067025531(10)AB2367(17)190713
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P150004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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: 07/13/2019
• Device Model Number: MN10450-50A
• Device Catalogue Number: MN10450-50A
• Device Lot Number: AB2367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Supplement Date Received by Manufacturer: 09/30/2026
• Initial Report FDA Received Date: 09/28/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2018
• 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 IPG; DRG LEAD (x2)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 230 LB