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

Model Number	6172
Medical Device Problem Code	Low impedance (2285)
Health Effect - Clinical Codes	Failure of Implant (1924); Movement Disorder (4412)
Date of Event	05/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient experienced ineffective therapy.System diagnostic recorded low impedances.Surgical intervention may take place to address the issue.The investigation was unable to determine the lead that was associated with the issue.
Additional Manufacturer Narrative
Reporter phone number (b)(6).Date of event is estimated.Additional components potentially involved in the event include: common device name: dbs lead, model: 6172, udi: (b)(4), serial: (b)(6) lot: 6141672.
Additional Manufacturer Narrative
It was reported that patient experienced ineffective therapy.System diagnostic recorded low impedances.Surgical intervention may take place at a later date to address the issue.The results of the investigation are inconclusive since the devices were not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.

• 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 19554546
• Report Number: 1627487-2024-09145
• Device Sequence Number: 12463920
• Product Code: MHY
• UDI-Device Identifier: 05415067020680
• UDI-Public: (01)05415067020680(10)6244858(17)190405
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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
• Report Date (Section B): 08/02/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/05/2019
• Device Model Number: 6172
• Device Catalogue Number: 6172
• Device Lot Number: 6244858
• 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: 05/24/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 08/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/05/2017
• 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 IPG; DBS LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown