MAUDE Adverse Event Report: ABBOTT MEDICAL OCTRODE LEAD; SCS LEAD

Model Number	3214
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.Further information was requested but not yet received.The unique device identifier (udi #) is unknown because the lot and part number were not provided.
Event or Problem Description
It was reported that patient was unable to place the system into mri mode.Diagnostics revealed impedances on the lead.As a result, surgical intervention may be undertaken to address the issue.
Additional Manufacturer Narrative
Correction: d4 - additional device information updated.
Event or Problem Description
Additional information indicates the lead was explanted and replaced on (b)(6) 2025.
Additional Manufacturer Narrative
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
Additional information received indicates that the impedances on the lead were high.Patient also experienced ineffective therapy.Therapy was restored post op.

• Brand Name: OCTRODE LEAD
• 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: 23813078
• Report Number: 1627487-2025-06173
• Device Sequence Number: 13082847
• Product Code: LGW
• UDI-Device Identifier: 05415067017789
• UDI-Public: (01)05415067017789(10)3847782(17)141028
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2025
• 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): 02/27/2026

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: 10/28/2014
• Device Model Number: 3214
• Device Catalogue Number: 3214
• Device Lot Number: 3847782
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 12/30/2025; 02/24/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/25/2026; 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2012
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 68 KG