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

Model Number	6172
Medical Device Problem Codes	Low impedance (2285); Impedance Problem (2950)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); Movement Disorder (4412)
Date of Event	12/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number: 1627487-2023-00111.Related manufacturer reference number: 1627487-2023-00112.It was reported that patient was not receiving therapy due to impedance issue.As such, surgical intervention took place on (b)(6) 2022 wherein the extension were explanted and replaced with new extensions.However, the issue was not resolved.Further impedance testing revealed that the impedance was on the left lead.As such, surgical intervention may take place at a later date to address the issue.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.
Event or Problem Description
Related manufacturer reference number: 1627487-2023-01747.Additional information received indicates that surgical intervention took place wherein the left lead with low impedance was explanted and replaced with a new lead to address the issue.The patient¿s right lead was also explanted and replaced with a new lead as it needed better placement.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Additional Manufacturer Narrative
Health effect - clinical code change from ¿2388 - inadequate pain relief¿ to ¿4412 - movement disorder¿.

• Brand Name: 8CH INFINITY DBS LEAD KIT, 40CM, 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: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 16121691
• Report Number: 1627487-2023-00110
• Device Sequence Number: 6533828
• Product Code: MHY
• UDI-Device Identifier: 05415067020680
• UDI-Public: 05415067020680
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/23/2023

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: 02/15/2019
• Device Model Number: 6172
• Device Catalogue Number: 6172
• Device Lot Number: 5857482
• 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: 12/16/2022
• Supplement Date Received by Manufacturer: 01/31/2023; 03/21/2023; 05/23/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 02/02/2023; 04/13/2023; 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2017
• 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 BURR HOLE CAP.; DBS IPG.; DBS LEAD.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 91 KG