MAUDE Adverse Event Report: ABBOTT MEDICAL OCTRODE LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number	3186
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the patient's explant procedure on (b)(6) 2025 [related manufacturer report number: 3006705815-2025-05370] one of the patients leads was broken and could not be explanted.As a result, surgical intervention may be undertaken to remove remaining portion of lead.The investigation was unable to determine the lead that is associated with the issue.
Additional Manufacturer Narrative
During processing of this complaint, attempts were made to obtain patient¿s weight.Further information was requested but not received.Additional components potentially involved in the event include: common device name: scs octrode lead, model: 3186, udi: (b)(4), serial: (b)(6); batch: 4636579.
Additional Manufacturer Narrative
Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.

• Brand Name: OCTRODE LEAD KIT, 60CM LENGTH
• Common Device Name: SCS LEAD
• 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: 22671789
• Report Number: 1627487-2025-03775
• Device Sequence Number: 3825365
• Product Code: LGW
• UDI-Device Identifier: 05414734406130
• UDI-Public: (01)05414734406130(10)4591282(17)160528
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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,Followup
• Report Date (Section B): 10/02/2025

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: 05/28/2016
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: 4591282
• 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: 07/09/2025
• Supplement Date Received by Manufacturer: 08/11/2025; 09/15/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 08/20/2025; 10/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2014
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male