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 Codes	Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event estimated.During processing of this incident, attempts were made to obtain complete device information.Further information was requested but not received.
Event or Problem Description
It was reported that during an ipg replacement (related manufacturer reference number: 3006705815-2024-05356) system diagnostics recorded high impedances but not out of range on the right lead.Patient also stated coverage was too high in the occipital area where the headaches are located.Surgical intervention took place where the leads was explanted and replaced to address the issue.Effective stimulation was restored.
Additional Manufacturer Narrative
Date of event estimated.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, 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: 20133079
• Report Number: 1627487-2024-10682
• Device Sequence Number: 7277594
• Product Code: LGW
• UDI-Device Identifier: 05414734401692
• UDI-Public: (01)05414734401692(10)3467807(17)130828
• 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: 2012
• 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): 11/10/2024

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: 08/28/2013
• Device Model Number: 3183
• Device Catalogue Number: 3183
• Device Lot Number: 3467807
• 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: 08/06/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 11/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2011
• 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: 44 YR
• Patient Sex: Female
• Patient Weight: 54 KG