MAUDE Adverse Event Report: ABBOTT MEDICAL 8-CHANNEL ADAPTER, MDT, 10CM; DBS ADAPTER

Model Number	2311
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had an infection at the left skull.As a result, surgical intervention was undertaken on (b)(6) 2023 wherein the adapter was explanted and replaced to address the issue.
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
Additional information indicates that the infection has resolved.Patient was given oral antibiotics.
Additional Manufacturer Narrative
A patient had an infection at the left skull was reported to abbott.It was determined the infection was at the competitor lead site and the lead adapter was explanted and replaced to address the issue.The patient was given oral antibiotics, and the infection has resolved.As a result, a device history record was performed to review and confirm the sterility of devices.Based on the documents reviewed, the source of the infection remains unknown.

• Brand Name: 8-CHANNEL ADAPTER, MDT, 10CM
• Common Device Name: DBS ADAPTER
• 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: 17561524
• Report Number: 1627487-2023-03884
• Device Sequence Number: 6854880
• Product Code: LGW
• UDI-Device Identifier: 05415067016119
• UDI-Public: 05415067016119
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 10/25/2023

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: 03/23/2023
• Device Model Number: 2311
• Device Lot Number: 7890239
• 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: 07/26/2023
• Supplement Date Received by Manufacturer: 08/30/2023; 10/22/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 09/21/2023; 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DBS BURR HOLE CAP; DBS EXTENSION; DBS IPG; DBS LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 68 KG