MAUDE Adverse Event Report: ABBOTT MEDICAL 8CH INFINITY DBS LEAD KIT, 30CM, 0.5, B

Model Number	6170
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
Related manufacturer report number: 1627487-2023-05732, 1627487-2023-05733, 1627487-2023-05735, 1627487-2023-05736.It was reported that the patient had an infection through the dbs system.As a result the system was explanted.Follow up indicated the patient's infection resolved without sequelae.
Additional Manufacturer Narrative
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: 8CH INFINITY DBS LEAD KIT, 30CM, 0.5, B
• Common Device Name: DBS 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: 18253861
• Report Number: 1627487-2023-05734
• Device Sequence Number: 14893095
• Product Code: MHY
• UDI-Device Identifier: 05415067030306
• UDI-Public: 05415067030306
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P140009
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2024

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: 02/21/2024
• Device Model Number: 6170
• Device Lot Number: 8340674
• 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: 11/09/2023
• Supplement Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 97 KG