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

Model Number	3189
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	01/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number:1627487-2023-00317.It was reported the patient is not receiving effective therapy due to invalid impedances.Surgical intervention may be pending to address the issue.
Additional Manufacturer Narrative
Date of event is estimated.
Additional Manufacturer Narrative
A patient experiencing invalid impedance was reported to abbott.No intervention is planned at this time.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.
Additional Manufacturer Narrative
A patient experiencing invalid impedance was reported to abbott.The patient's leads were explanted and replaced.Therapy was restored.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 event could not be conclusively determined.
Event or Problem Description
Surgical intervention occurred where the leads were explanted and replaced.Therapy was restored post procedure.

• Brand Name: OCTRODE LEAD KIT, 90CM LENGTH
• Common Device Name: 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: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 16233769
• Report Number: 1627487-2023-00318
• Device Sequence Number: 6972902
• Product Code: LGW
• UDI-Device Identifier: 05414734406147
• UDI-Public: 05414734406147
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 04/24/2023

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: 07/28/2016
• Device Model Number: 3189
• Device Catalogue Number: 3189
• Device Lot Number: 4711932
• 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: 01/03/2023
• Supplement Date Received by Manufacturer: 01/24/2023; 03/30/2023
• Initial Report FDA Received Date: 01/24/2023
• Supplement Report FDA Received Date: 01/27/2023; 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2014
• 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 IPG X1.; SCS LEAD ANCHOR X2.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 54 KG