MAUDE Adverse Event Report: ABBOTT MEDICAL QUATTRODE LEAD, 3/4MM, 60 CM; SCS LEAD

Model Number	3146
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	03/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The date of event is estimated.The allegation is against 1 of 4 leads; however, it is unknown which lead; therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: quattrode lead, 3/4mm, 60 cm, model: 3146, udi: (b)(4), batch: 175088.Common device name: quattrode lead, 3/4mm, 60 cm, model: 3146, udi: (b)(4), batch: 175088.Common device name: quattrode lead, 3/4mm, 60 cm, model: 3146, udi: (b)(4), batch: 175088.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
Event or Problem Description
It was reported that one of the patient's leads migrated.It is unknown which lead was at fault.As a result, surgical intervention was undertaken wherein the lead was repositioned to resolve the issue.

• Brand Name: QUATTRODE LEAD, 3/4MM, 60 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: 24737507
• Report Number: 1627487-2026-01538
• Device Sequence Number: 9270053
• Product Code: LGW
• UDI-Device Identifier: 05414734401586
• UDI-Public: (01)05414734401586(10)175088(17)101128
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/30/2026

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: 11/28/2010
• Device Model Number: 3146
• Device Catalogue Number: 3146
• Device Lot Number: 175088
• 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: 03/02/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2008
• 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 IPG; SCS LEAD (X3)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 68 KG