MAUDE Adverse Event Report: ABBOTT MEDICAL LAMITRODE TRIPOLE 16 LEAD, 60 CM; SCS LEAD

Model Number	3219
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Numbness (2415); Implant Pain (4561)
Date of Event	11/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.Further information has been requested but not yet received.
Event or Problem Description
It was reported that patient is experiencing spinal cord compression.As a result, surgical intervention may be undertaken to address the issue.
Additional Manufacturer Narrative
Correction h6 health effect - clinical code.
Event or Problem Description
Additional information indicates that patient's weight was fluctuating, and patient was experiencing numbness and tingling due to spinal cord compression.Patient also experienced pain at the ipg site.As a result, surgical intervention was undertaken on (b)(6) 2024 wherein lead was explanted and replaced, and the ipg was repositioned to address the issue.Patient symptoms are improving.
Additional Manufacturer Narrative
The results of the investigation are inconclusive 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.

• Brand Name: LAMITRODE TRIPOLE 16 LEAD, 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 20800947
• Report Number: 1627487-2024-12212
• Device Sequence Number: 18116395
• Product Code: LGW
• UDI-Device Identifier: 05414734406161
• UDI-Public: (01)05414734406161(10)5771415(17)181215
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: 2024
• 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): 02/05/2025

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: 12/15/2018
• Device Model Number: 3219
• Device Catalogue Number: 3219
• Device Lot Number: 5771415
• 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: 11/06/2024
• Supplement Date Received by Manufacturer: 12/23/2024; 01/29/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/10/2025; 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2016
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 77 KG