MAUDE Adverse Event Report: ABBOTT MEDICAL STYLET, BENT, 60CM; SCS STYLET

Model Number	1124
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The allegation is against 1 of 3 stylets; however, it is unknown which stylet; therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: stylet, straight, 60cm, model: 1123, udi: (b)(4), batch: 11324348.Common device name: stylet, bent, 60cm, model: 1124, udi: (b)(4), batch: 10511747.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
It was reported that during a lead revision [related manufacturer reference number: 3006705815-2026-03043; 3006705815-2026-03044] the stylet was left implanted, and the physician opted to cut the stylet and leave it partially implanted in the patient.There were no adverse consequences to the patient.It is unknown which stylet was at fault.

• Brand Name: STYLET, BENT, 60CM
• Common Device Name: SCS STYLET
• 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 ; 9723098000
• MDR Report Key: 25256843
• Report Number: 1627487-2026-08022
• Device Sequence Number: 20191597
• Product Code: LGW
• UDI-Device Identifier: 05414734400213
• UDI-Public: (01)05414734400213(10)10511747(17)260924
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Report Date (Section B): 05/22/2026

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: 09/24/2026
• Device Model Number: 1124
• Device Catalogue Number: 1124
• Device Lot Number: 10511747
• 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: 04/29/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2024
• 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 (X2).; SCS IPG.; SCS LEAD (X2).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 127 KG