MAUDE Adverse Event Report: ABBOTT MEDICAL MULTILEAD TRIAL CABLE

Model Number	3013
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure an expired mltc cable was used.No adverse effects have been reported.
Additional Manufacturer Narrative
The directions for use states that the implant must be charged every 30 days to avoid battery depletion.Based on the information received, the cause of the reported incident is related to user error.

• Brand Name: MULTILEAD TRIAL CABLE
• Common Device Name: MULTILEAD TRIAL CABLE
• 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: 22080339
• Report Number: 1627487-2025-02495
• Device Sequence Number: 21207688
• Product Code: LGW
• UDI-Device Identifier: 05414734405355
• UDI-Public: (01)05414734405355(10)8963371(17)250329
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/29/2025
• Device Model Number: 3013
• Device Catalogue Number: 3013
• Device Lot Number: 8963371
• 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: 05/13/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2023
• 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 LEADX2.
• Patient Sex: Female
• Patient Weight: 82 KG