MAUDE Adverse Event Report: ABBOTT MEDICAL QUATTRODE LEAD WIDE SPACED, 90 CM; SCS LEAD

Model Number	3169
Medical Device Problem Codes	High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Failure of Implant (1924); Undesired Nerve Stimulation (1980); Inadequate Pain Relief (2388)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient was experiencing uncomfortable and ineffective therapy.Trouble shooting was unable to solve the issue.As such surgical intervention may be pending to address the issue.
Additional Manufacturer Narrative
B3: date of event is estimated.The allegation is against 1 of 2 leads; however, it is unknown which lead, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: scs occipital lead, model: 3189, udi: (b)(4), serial:(b)(6), batch:5728527.
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 indicated that patient underwent surgical intervention on (b)(6) 2024 where the left eft supra-orbital lead replaced with a new one and therapy restored.
Additional Manufacturer Narrative
Updated h6 and captured product problem in b1.

• Brand Name: QUATTRODE LEAD WIDE SPACED, 90 CM
• 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: 19036733
• Report Number: 1627487-2024-07885
• Device Sequence Number: 20600366
• Product Code: LGW
• UDI-Device Identifier: 05414734406116
• UDI-Public: (01)05414734406116(10)5649123(17)180921
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 06/11/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/21/2018
• Device Model Number: 3169
• Device Lot Number: 5649123
• 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: 03/12/2024
• Supplement Date Received by Manufacturer: 05/30/2024; 06/11/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 06/10/2024; 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2016
• 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 X 2; SCS EXTENSION X 4; SCS IPG; SUPRA-ORBITAL X 3 LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 150 KG