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

Model Number	3183
Medical Device Problem Codes	High impedance (1291); Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	01/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
Related manufacturer report number: 1627487-2024-00381.It was reported that the patient had high impedances on both implanted leads as well as both implanted leads had migrated.X-rays taken intraoperatively confirmed both leads had migrated.As a result, surgical intervention was undertaken on (b)(6) 2024 wherein both patient's leads were explanted and replaced to address the issue.
Additional Manufacturer Narrative
The event of ipg replacement/lead revision was reported to abbott.The ipg was explanted and replaced due to ipg reaching end of life.Lead diagnostics showed high impedance.X-ray confirmed lead migration for both leads.Patient had a full system explant and implant.The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determined.

• 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: 18561352
• Report Number: 1627487-2024-00382
• Device Sequence Number: 12771008
• Product Code: LGW
• UDI-Device Identifier: 05414734406123
• UDI-Public: 05414734406123
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• 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): 01/30/2024

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: 01/28/2015
• Device Model Number: 3183
• Device Lot Number: 3932283
• 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: 01/02/2024
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2013
• 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 (3).; SCS IPG.; SCS LEAD EXTENSION (2).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 91 KG