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

Model Number	6172
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event estimated.
Event or Problem Description
It was reported that the patient was unable to put their right system into mri mode.Troubleshooting took place but were unable to connect to the device.Surgical intervention took place where the entire system was explanted to address the issue.
Additional Manufacturer Narrative
Date of event estimated.The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to 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: 20678200
• Report Number: 1627487-2024-11899
• Device Sequence Number: 18241477
• Product Code: MHY
• UDI-Device Identifier: 05415067020680
• UDI-Public: (01)05415067020680(10)6024536(17)190620
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 01/22/2025

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: 06/20/2019
• Device Model Number: 6172
• Device Catalogue Number: 6172
• Device Lot Number: 6024536
• 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: 10/17/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2017
• 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 EXTENSION; DBS IPG
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 91 KG