MAUDE Adverse Event Report: ABBOTT MEDICAL QUATTRODE LEAD WIDE SPACED, 90 CM; SCS LEAD

Model Number	3169
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.Additional components potentially involved in the event include: common device name: quattrode, model: 3169, udi: (b)(4), serial: (b)(6), batch: 6042358.
Event or Problem Description
It was reported the patient's left occipital lead had high impedances.Surgical intervention may be pending to address the issue.Note : it is unknown which lead is related to this issue.
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 event could not be conclusively determined.
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 event could not be conclusively determined.
Event or Problem Description
Additional information received indicates the patient had ineffective therapy due to both occipital leads had high impedance.Surgical intervention took place wherein the leads were explanted and replaced.Effective therapy restored.

• Brand Name: QUATTRODE LEAD WIDE SPACED, 90 CM
• 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: 22558310
• Report Number: 1627487-2025-03562
• Device Sequence Number: 18535941
• Product Code: LGW
• UDI-Device Identifier: 05414734406116
• UDI-Public: (01)05414734406116(10)6042358(17)190703
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 09/23/2025

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: 07/03/2019
• Device Model Number: 3169
• Device Catalogue Number: 3169
• Device Lot Number: 6042358
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 08/01/2025; 08/28/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/05/2025; 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2017
• 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 ADAPTERX2.; SCS ANCHORX2.; SCS IPG.; SCS LEADX3.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 68 KG