MAUDE Adverse Event Report: ABBOTT MEDICAL LAMITRODE S-8 LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3286

Device Problem High impedance (1291)

Patient Problems Failure of Implant (1924); Inadequate Pain Relief (2388)

Event Date 02/05/2024

Event Type  Injury  

Event Description

It was reported that the patient experienced ineffective therapy with their scs system due to high impedances present on the patient's leads.As a result, surgical intervention was undertaken on (b)(6) 2024 wherein the patient's leads were explanted and replaced to address the issue.Effective therapy was restored post-op.

Manufacturer Narrative

Date of event is estimated.

• Brand Name: LAMITRODE S-8 LEAD KIT, 60CM LENGTH
• Type of Device: 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 19153148
• MDR Text Key: 340726442
• Report Number: 1627487-2024-08247
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734402231
• UDI-Public: (01)05414734402231(10)5299638(17)171031
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2024

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: 3286
• Device Lot Number: 5299638
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SCS IPG
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 70 KG