MAUDE Adverse Event Report: ABBOTT MEDICAL 8CH INFINITY DBS LEAD KIT, 40CM, 0.5, B

Model Number 6172

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Date 07/16/2022

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.During processing of this complaint, attempts were made to obtain complete patient information.The device history record was reviewed to ensure proper packaging and sterility.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 Description

Related manufacturer reference number:1627487-2022-04188.Related manufacturer reference number:1627487-2022-05357.It was reported that the patient had an open wound on top of the guardian burr hole cover on the left.As a result, surgical intervention was undertaken wherein the wound was irrigated.The patient was administered iv antibiotics.It is unknown which burr hole cover has the open wound.Additional information indicates surgical intervention was undertaken on (b)(6) 2022 wherein the left side of the system was explanted to address the issue.

• Brand Name: 8CH INFINITY DBS LEAD KIT, 40CM, 0.5, B
• Type of Device: 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: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 15545217
• MDR Text Key: 301204495
• Report Number: 1627487-2022-05356
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067030320
• UDI-Public: 05415067030320
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2023
• Device Model Number: 6172
• Device Catalogue Number: 6172
• Device Lot Number: 8075614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DBS BURR HOLE CAP; DBS EXTENSION; DBS IPG; DBS LEAD
• Patient Outcome(s): Other
• Patient Sex: Female