MAUDE Adverse Event Report: ABBOTT MEDICAL LAMITRODE 88 LEAD KIT, 60CM LENGTH; SCS PADDLE LEAD

Model Number	3288
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent surgical procedure on (b)(6) 2022 wherein the cervical wound was washed out due to postoperative infection or hematoma.
Event or Problem Description
Additional information was received indicating the patient had an infection, no hematoma.The infection was treated via antibiotics and the 12 may procedure.Infection has resolved.
Additional Manufacturer Narrative
An event of infection was reported to abbott.The location of the infection site was not conveyed, and no products were returned for analysis.As a result, a device history record was performed to review and confirm the sterility of all implanted devices.Based on the documents reviewed, the source of the infection could not be conclusively determined.

• Brand Name: LAMITRODE 88 LEAD KIT, 60CM LENGTH
• Common Device Name: SCS PADDLE 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: 14495809
• Report Number: 1627487-2022-02969
• Device Sequence Number: 6191519
• Product Code: LGW
• UDI-Device Identifier: 05414734402248
• UDI-Public: 05414734402248
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2022

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: 07/16/2022
• Device Model Number: 3288
• Device Catalogue Number: 3288
• Device Lot Number: 7585575
• 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: 05/11/2022
• Supplement Date Received by Manufacturer: 06/05/2022; 08/23/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 06/23/2022; 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown