MAUDE Adverse Event Report: ABBOTT MEDICAL EXTENSION, DUAL 4 CHANNEL 10CM; SCS EXTENSION

Model Number	3341
Medical Device Problem Codes	High impedance (1291); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); Insufficient Information (4580)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: event date is estimated.The allegation is against one of three extensions; however, it is unknown which lead, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: extension, model: 3341, udi: (b)(4), batch: 5864426, 5689655.
Event or Problem Description
It was reported that the patient had an extension replacement for an unknown reason.The investigation did not determine which extension attributed to this issue.
Event or Problem Description
Additional information indicates the patient experienced ineffective therapy and one of the extensions exhibited high impedances.Surgical intervention was undertaken on (b)(6) 2025, wherein the extension was explanted and replaced to address the issue.Therapy was restored post procedure.It is unknown which extension attributed to this issue.
Additional Manufacturer Narrative
During processing of this complaint, attempts were made to obtain complete patient information.The allegation is against one of three extensions; however, it is unknown which extension, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: extension, model: 3341, udi: (b)(4), batch: 5689655 common device name: extension, model: 3341, udi: (b)(4), batch: 6854121 d4 correction: lot number should be 5864426 rather than 6854121.D4 correction: expiration date should be 22feb2019 rather than 18feb2021.D6a correction: implant date should be (b)(6) 2017, rather than (b)(6) 2019.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 event could not be conclusively determined.

• Brand Name: EXTENSION, DUAL 4 CHANNEL 10CM
• 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: 23660177
• Report Number: 1627487-2025-05878
• Device Sequence Number: 10055211
• Product Code: LGW
• UDI-Device Identifier: 05414734402279
• UDI-Public: (01)05414734402279(10)6854121(17)210218
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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
• 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: 02/22/2019
• Device Model Number: 3341
• Device Catalogue Number: 3341
• Device Lot Number: 5864426
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2019
• 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 (X2); SCS EXTENSION (X2); SCS IPG; SCS LEAD (X3)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Sex: Female