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

Model Number	3214
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.Db6 date of explant- exact date of explant is unknown.Section a4: during processing of this incident, attempts were made to obtain complete patient information (weight); however, no further information was received.
Event or Problem Description
It was reported that the patient's lead was explanted for an unknown reason at an unknown date several years ago.
Additional Manufacturer Narrative
This event is no longer reportable.
Event or Problem Description
Additional information received indicates, patient's scs system was explanted electively at an unknown date due to the patient needing mri.There were no allegations against the scs system.Therefore, the event is no longer reportable.

• Brand Name: LAMITRODE TRIPOLE 16C 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: 21088416
• Report Number: 1627487-2025-00117
• Device Sequence Number: 6728240
• Product Code: LGW
• UDI-Device Identifier: 05414734401784
• UDI-Public: (01)05414734401784(10)2825271(17)110728
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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: 07/28/2011
• Device Model Number: 3214
• Device Catalogue Number: 3214
• Device Lot Number: 2825271
• 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: 12/17/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2009
• 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 EXTENSION (X2); SCS IPG
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male