MAUDE Adverse Event Report: ABBOTT MEDICAL OCTRODE LEAD KIT, 30CM LENGTH; SCS LEAD

Model Number	3183
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number: 1627487-2023-03181.Related manufacturer reference number: 1627487-2023-03182.Related manufacturer reference number: 1627487-2023-03184.It was reported that the patient never experienced effective therapy from their occipital scs system for their migraines.The ipg for their occipital system in inoperable.Additionally, the patient experienced ineffective therapy from their lumbar scs system due to high and low impedances.Reprogramming was unable to resolve the issue.As such, surgical intervention may take place at a later date to address the issue.Investigation was unable to determine which of the occipital leads attributed to the ineffective therapy.
Additional Manufacturer Narrative
Date of event is estimated.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
Additional information received indicates that surgical intervention took place on (b)(6) 2023 wherein the occipital system was explanted to address the issue with this system.Additionally, the lumbar system was also explanted and replaced with a new system to address the issue with the lumbar system.Reportedly, therapy was restored post operatively.

• Brand Name: OCTRODE LEAD KIT, 30CM 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: 17280924
• Report Number: 1627487-2023-03183
• Device Sequence Number: 3566729
• Product Code: LGW
• UDI-Device Identifier: 05414734401692
• UDI-Public: 05414734401692
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 10/09/2023

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: 10/28/2014
• Device Model Number: 3183
• Device Catalogue Number: 3183
• Device Lot Number: 3829143
• 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: 06/12/2023
• Supplement Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2012
• 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; SCS IPG
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 73 KG