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

Model Number	3169
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Post Operative Wound Infection (2446)
Date of Event	12/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient experienced suspected infection and allergy at the left supraorbital lead site.Patient's body was rejecting the left supraorbital lead and was hospitalized.As a result, surgical intervention was undertaken on (b)(6) 2023 wherein the lead was explanted to address the issue.The patient was administered both oral and iv antibiotics to address the issue.
Additional Manufacturer Narrative
The date of event is estimated.
Additional Manufacturer Narrative
Correction: pma/510(k) # was inadvertently omitted from the initial and subsequent reports.The device history record was reviewed to ensure proper packaging and sterility.Based on the information received, the cause of the reported incident could not be conclusively determined.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
Event or Problem Description
Additional information indicates that the infection has resolved.
Additional Manufacturer Narrative
Correction: h6: codes were updated to reflect infection.
Event or Problem Description
Additional information indicates that the patient had an infection at the lead site and patient is continuing iv antibiotics.The infection has since resolved.

• 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: 18527541
• Report Number: 1627487-2024-00268
• Device Sequence Number: 20428927
• Product Code: LGW
• UDI-Device Identifier: 05414734406116
• UDI-Public: 05414734406116
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 04/15/2024

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: 09/26/2024
• Device Model Number: 3169
• Device Lot Number: 8674908
• 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: 12/28/2023
• Supplement Date Received by Manufacturer: 01/19/2024; 02/07/2024; 04/11/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 02/12/2024; 02/28/2024; 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2022
• 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 EXTENSION.; SCS IPG.; SCS LEAD.
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 55 KG