MAUDE Adverse Event Report: Abbott Medical Swift-Lock Anchor; Stimulator, Spinal-Cord, Implanted (Pain Relief)

Model Number	1192
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	08/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient lost effective therapy and was unable to enter mri mode due to lead and anchor fractures.The issue was confirmed via x-rays, though investigation was unable to identify which lead and anchor they were.Surgical intervention may be pending to address the issue.
Additional Manufacturer Narrative
Date of event is estimated.Additional components potentially involved in the event include: common device name: scs anchor, model: 1192, udi: (b)(4), serial: n/a, batch: 10962335.

• Brand Name: Swift-Lock Anchor
• Common Device Name: Stimulator, Spinal-Cord, Implanted (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: 50777616
• Report Number: 1627487-2026-10086
• Device Sequence Number: 15909210
• Product Code: GZB
• UDI-Device Identifier: 05415067024084
• UDI-Public: (01)05415067024084(10)10962335(17)270811
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K092371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 09/16/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 10962335
• 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: 09/14/2026
• Supplement Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 09/15/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2025
• 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: SCS ANCHOR; SCS IPG; SCS LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 150 LB