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	12/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer report number: 1627487-2024-00008.It was reported that wound dehiscence was observed at the patient's right dbs lead site.As a result, the patient underwent surgical intervention during which the right lead and burr hole cover were explanted, resolving the issue.The patient was put on antibiotics post-operatively.
Additional Manufacturer Narrative
Date of event is estimated.Initial reporter phone number: (b)(6).
Event or Problem Description
Additional information received indicates that the patient's infection had resolved.
Additional Manufacturer Narrative
A patient infection was reported to abbott.It was determined the wound dehiscence was observed at the patient's right dbs lead site.The patient underwent surgical intervention during which the right lead and burr hole cover were explanted.The patient was put on antibiotics to address the issue.The infection has since 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: 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: 18429267
• Report Number: 1627487-2024-00007
• Device Sequence Number: 18078575
• Product Code: MHY
• UDI-Device Identifier: 05415067030306
• UDI-Public: 05415067030306
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P140009
• 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
• Report Date (Section B): 04/21/2024

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: 10/05/2024
• Device Model Number: 6170
• Device Lot Number: 8696524
• 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: 12/18/2023
• Supplement Date Received by Manufacturer: 01/15/2024; 04/12/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 01/31/2024; 04/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2022
• 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: DBS IPG.; DBS LEAD EXTENSION (X2).; DBS LEAD.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 60 KG