MAUDE Adverse Event Report: ABBOTT MEDICAL OCTRODE LEAD KIT, 90CM LENGTH; SCS PERCUTANEOUS LEAD

Model Number	3189
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	10/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section b3: date of event is estimated.The allegation is against 1 of 2 leads; however, it is unknown which lead, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: scs octrode lead, model: 3189, udi: (b)(4), serial: (b)(6), batch: 7143305.
Event or Problem Description
Related manufacturer reference number: 3006705815-2023-06802.It was reported that patient experienced ineffective stimulation.Surgical intervention was undertaken wherein the leads were explanted and replaced with a paddle lead.Therapy was restored.
Additional Manufacturer Narrative
Section h10 - result of investigation was not included in previous report and has been added.A patient had their system explanted and replaced due to ineffective stimulation was reported to abbott.Therapy was restored.The results of the investigation are inconclusive since the devices were not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.

• Brand Name: OCTRODE LEAD KIT, 90CM LENGTH
• Common Device Name: SCS PERCUTANEOUS 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: 17990094
• Report Number: 1627487-2023-05017
• Device Sequence Number: 7259482
• Product Code: LGW
• UDI-Device Identifier: 05414734406147
• UDI-Public: 05414734406147
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• 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): 10/25/2023

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: 10/28/2016
• Device Model Number: 3189
• Device Lot Number: 4867478
• 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: 10/10/2023
• Supplement Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2014
• 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 (1); SCS ANCHOR (1); SCS IPG (1); SCS PERCUTANEOUS LEAD (1)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 94 KG