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

Model Number	3219
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); Implant Pain (4561)
Date of Event	05/24/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.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.
Event or Problem Description
It was reported in medwatch report mw5160174 that patient was experiencing pain at lead site, x-ray imaging revealed patients lead migrated.As a result, surgical intervention was undertaken on an unknown date wherein patients system was explanted to address the issue.

• 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: 20748108
• Report Number: 1627487-2024-12126
• Device Sequence Number: 12833938
• Product Code: LGW
• UDI-Device Identifier: 05414734406161
• UDI-Public: (01)05414734406161(10)5010578(17)170131
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/21/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: 3219
• Device Catalogue Number: 3219
• Device Lot Number: 5010578
• 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: 10/30/2024
• Initial Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2015
• 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 ANCHOR (X2); SCS IPG
• Outcome Attributed to Adverse Event: Other
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 116 KG