MAUDE Adverse Event Report: ABBOTT MEDICAL EXTENSION, 30CM; SCS EXTENSION

Model Number	3383
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had ineffective therapy due to high impedances on their extension.Surgical intervention was undertaken, and the extension was explanted and replaced.
Additional Manufacturer Narrative
B3: event date is estimated.
Additional Manufacturer Narrative
The reported event for high impedance was confirmed.As returned, visual inspection did show not show anomaly but failed the channel resistance test which will cause the high impedance and loss of therapy.The cause of the issue is unknown.

• Brand Name: EXTENSION, 30CM
• Common Device Name: SCS EXTENSION
• 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: 23870816
• Report Number: 1627487-2025-06299
• Device Sequence Number: 14784801
• Product Code: LGW
• UDI-Device Identifier: 05414734402323
• UDI-Public: (01)05414734402323(10)8499500(17)240531
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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: 05/31/2024
• Device Model Number: 3383
• Device Catalogue Number: 3383
• Device Lot Number: 8499500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2025
• 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: 11/26/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• 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: Unknown