MAUDE Adverse Event Report: ABBOTT MEDICAL 8CH INFINITY DBS LEAD KIT, 40CM, 1.5, B

Model Number 6173

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

Patient Problem Unspecified Infection (1930)

Event Date 11/30/2023

Event Type  Injury  

Event Description

Related manufacturer reference number: 1627487-2023-06059, related manufacturer reference number: 1627487-2023-06060, related manufacturer reference number: 1627487-2023-06061, related manufacturer reference number: 1627487-2023-06062.It was reported that patient experienced infection at ipg and extension sites, and there is a possible infection at the lead site.As a result.Surgical intervention was undertaken on (b)(6) 2023 wherein ipg and extensions were explanted to address the issue.Patient was administered oral antibiotics and hospitalized post-op to address the issue.Additional surgical intervention may be undertaken to address the possible infection of the leads.

Manufacturer Narrative

Date of event is estimated.Further information has been requested but not yet received.

Manufacturer Narrative

Further information was requested but not received.A patient experienced infection at ipg and extension sites, and there is a possible infection at the lead site was reported to abbott.The ipg and extensions were explanted to address the issue.Patient was administered oral antibiotics and hospitalized post-op to address the issue.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.The results of the investigation are inconclusive 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.

Manufacturer Narrative

Additional information was requested but not received.

Event Description

Additional information indicates that there was an infection at the lead site.As a result, surgical intervention was under taken on (b)(6) 2024 wherein leads were explanted to address the issue.

Manufacturer Narrative

An event of infection was reported to abbott.It was conveyed that the infection originates at the ipg, lead(s), extension(s) site(s).The entire system was explanted; however, no explanted products were returned for analysis.The patient was administered oral antibiotics and hospitalized post-op to address the issue.As a result, a device history record was performed to review and confirm the sterility of the lead(s), extension(s).Based on the documents reviewed, the source of the infection remains unknown.The results of the investigation are inconclusive 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.

• Brand Name: 8CH INFINITY DBS LEAD KIT, 40CM, 1.5, 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 18376715
• MDR Text Key: 331178588
• Report Number: 1627487-2023-06063
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067030337
• UDI-Public: 05415067030337
• 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,Followup,Followup,Followup
• Report Date: 04/30/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2021
• Device Model Number: 6173
• Device Lot Number: 6974899
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 01/29/2024; 02/09/2024; 04/23/2024
• Supplement Dates FDA Received: 02/05/2024; 02/28/2024; 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/06/2019
• 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
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 61 KG