MAUDE Adverse Event Report: ABBOTT MEDICAL LAMITRODE 4 LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number	3240
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	12/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number: 1627487-2024-00199, 1627487-2024-00200, 1627487-2024-00201.It was reported patient's scs system did not provide effective therapy and was explanted on (b)(6) 2023.
Additional Manufacturer Narrative
Date of event is estimated.
Additional Manufacturer Narrative
The report of ¿ineffective therapy¿ was not able to be confirmed.Analysis of the returned lead b found it had been cut during the explant procedure resulting a stimulation end segment and a terminal end segment.The complete lead was not returned.The two segments that were returned passed continuity testing (no opens found).

• Brand Name: LAMITRODE 4 LEAD KIT, 60CM LENGTH
• 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: 18480101
• Report Number: 1627487-2024-00202
• Device Sequence Number: 6924007
• Product Code: LGW
• UDI-Device Identifier: 05414734402033
• UDI-Public: 05414734402033
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/02/2018
• Device Model Number: 3240
• Device Lot Number: 5903478
• 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: 12/22/2023
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2016
• 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