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

Model Number	3189
Medical Device Problem Codes	Fracture (1260); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Inadequate Pain Relief (2388); Insufficient Information (4580)
Date of Event	11/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event estimated.During processing of this incident, attempts were made to obtain complete event information.Further information was requested but not received.
Event or Problem Description
It was reported that surgical intervention took place on the patient's cervical system where the ipg and lead were explanted and replaced.The reason for replacement surgery is unknown at this time.Effective stimulation was restored.Investigation was unable to determine which of the leads attributed to the event.
Event or Problem Description
Additional information indicates that patient experienced ineffective therapy, x-ray imaging revealed patients lead was fractured.Patient¿s ipg had reached end of life, and it is unknown if this occurred prematurely.Surgical intervention was undertaken on (b)(6) 2024 wherein patients' system was explanted and replaced to address the issue.The investigation was unable to determine the lead that associated with the issue.
Additional Manufacturer Narrative
Correction h11- should include: additional components potentially involved in the event include: common device name: lead, model: 3189, udi: (b)(4), serial: (b)(6), batch: 4899324.
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.

• Brand Name: OCTRODE LEAD KIT, 90CM 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: 20872536
• Report Number: 1627487-2024-12463
• Device Sequence Number: 21032890
• Product Code: LGW
• UDI-Device Identifier: 05414734406147
• UDI-Public: (01)05414734406147(10)4899324(17)161228
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: 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,Followup
• Report Date (Section B): 02/12/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/28/2016
• Device Model Number: 3189
• Device Catalogue Number: 3189
• Device Lot Number: 4899324
• 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: 11/17/2024
• Supplement Date Received by Manufacturer: 01/13/2025; 02/05/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 02/05/2025; 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2014
• 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 ANCHORS (X2); SCS LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 79 KG