MAUDE Adverse Event Report: Abbott Medical Octrode Lead Kit, 90cm Length; Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Model Number	3189
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had the abbott ipg and one lead replaced at an unknown date with a competitor product.Recently, the system, including the one remaining abbott lead was found to have high impedances.As a result, surgical intervention was undertaken on (b)(6) 2026 where the system was removed and replaced to address the issue.
Additional Manufacturer Narrative
Date of event is unknown.Date of explant is unknown.

• Brand Name: Octrode Lead Kit, 90cm Length
• Common Device Name: Stimulator, Spinal-Cord, Totally Implanted 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: 50421043
• Report Number: 1627487-2026-09651
• Device Sequence Number: 10592671
• Product Code: LGW
• UDI-Device Identifier: 05414734401715
• UDI-Public: (01)05414734401715(10)7224221(17)211013
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 09/10/2026

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: 10/13/2021
• Device Model Number: 3189
• Device Catalogue Number: 3189
• Device Lot Number: 7224221
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 08/24/2026
• Supplement Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2019
• 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 x 2.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 165 LB