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

Model Number 6172

Device Problem Use of Device Problem (1670)

Patient Problem Movement Disorder (4412)

Event Date 02/01/2024

Event Type  Injury  

Manufacturer Narrative

A case of incorrect placement / lead replacement was reported to abbott.The patient had their two leads (6172ans) explanted on (b)(6) 2024 due to an incorrect lead placement in their first stage 1 and had new leads re-implanted.The event information pertaining to this incident has been reviewed and no product investigation can be performed as there are no complaint allegations present nor were the circumstances of the event attributed to the implanted leads.

Event Description

Related manufacturer report number: 1627487-2024-07115.It was reported that the patient was experiencing ineffective therapeutic relief from their dbs leads due to an incorrect lead placement from their initial implant procedure.Surgical intervention was undertaken on (b)(6) 2024 wherein the patient's dbs leads were explanted and replaced 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 18750737
• MDR Text Key: 335895924
• Report Number: 1627487-2024-07113
• Device Sequence Number: 1
• Product Code: MHY
• 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: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6172
• Device Lot Number: 8605143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2022
• 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 (X2); DBS IPG (X1); DBS LEAD EXTENSION (X2)
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 59 KG