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 Code	Post Operative Wound Infection (2446)
Date of Event	05/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced an infection at the lead site.Antibiotic treatment did not address the issue.Patient is hospitalized.Surgical intervention took place wherein a wound wash out was performed to address the issue.
Event or Problem Description
Additional information received indicates that the wound wash out was performed on (b)(6) 2023.The infection has resolved.Patient was released from the hospital after a week of antibiotics.
Event or Problem Description
Related manufacturer reference number: 1627487-2023-04530.Related manufacturer reference number: 1627487-2023-04616.Related manufacturer reference number: 1627487-2023-04617.Additional information received indicates that the patient had anchors implanted, which were also explanted on (b)(6) 2023.
Event or Problem Description
Related manufacturer reference number: 1627487-2023-04530.Additional information received indicates that infection did not resolve and spread to the ipg site.As such, surgical intervention took place on (b)(6) 2023 wherein the lead and ipg were explanted to address the issue.The infection was being treated in hospital with iv antibiotics, post procedure of device removal.The patient has now been discharged.
Additional Manufacturer Narrative
A review of the lot history record identified no manufacturing nonconformities issued to the reported device that would have contributed to this event.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 received indicates that the doctor has indicated that the infection has cleared and iv antibiotics have been stopped.

• 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 17035008
• Report Number: 1627487-2023-02614
• Device Sequence Number: 6393979
• 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
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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,Followup,Followup
• Report Date (Section B): 10/10/2023

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: 10/06/2023
• Device Model Number: 3288
• Device Catalogue Number: 3288
• Device Lot Number: 8166631
• 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: 05/08/2023
• Supplement Date Received by Manufacturer: 06/01/2023; 09/01/2023; 09/01/2023; 09/28/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 06/23/2023; 09/22/2023; 09/27/2023; 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2021
• 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; Hospitalization
• Patient Sex: Female