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	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight estimated.Additional components potentially involved in the event include: common device name: drg lead, mode: mn10450-50a , udi:(b)(4), serial: n/a, ab2296:.
Event or Problem Description
It was reported that during a lead revision on 21aug2026 (related manufacturer reference number:1627487-2026-01395) a portion of lead was left implanted.As such, surgical intervention may take place at a later date to address the issue.Investigation was unable to determine which of the leads is the left lead.

• 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: 50755119
• Report Number: 1627487-2026-09985
• Device Sequence Number: 9550447
• Product Code: PMP
• UDI-Device Identifier: 05415067025531
• UDI-Public: (01)05415067025531(10)AB2283(17)190407
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P150004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 09/21/2026

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: 04/07/2019
• Device Model Number: MN10450-50A
• Device Catalogue Number: MN10450-50A
• Device Lot Number: AB2283
• 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: 08/20/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/14/2026
• Supplement Report FDA Received Date: 09/21/2026
• 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 IPG; DRG Lead
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 170 LB