MAUDE Adverse Event Report: ABBOTT MEDICAL 8CH INFINITY DBS LEAD KIT, 30CM, 0.5, B

Model Number	6170
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Paralysis (1997)
Date of Event	08/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number: 1627487-2021-17183.It was reported following the implant procedure the patient experienced left hemiparesis and dysarthria worsening.The symptoms have begun to improve on their own.No further intervention is planned at this time.
Additional Manufacturer Narrative
It was reported following the implant procedure the patient experienced left hemiparesis and dysarthria worsening.The symptoms have begun to improve on their own.No further intervention is planned at this time.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.
Event or Problem Description
Additional information was obtained indicating that the patient now has disartry and right facial palsy, walking instability, and worsening of parkinsonism symptoms resulting in hospitalization.
Event or Problem Description
Additional information was received indicating the issue was resolved with medication.

• Brand Name: 8CH INFINITY DBS LEAD KIT, 30CM, 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: 12515444
• Report Number: 1627487-2021-17184
• Device Sequence Number: 16395994
• Product Code: MHY
• UDI-Device Identifier: 05415067020635
• UDI-Public: 05415067020635
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/24/2021

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: 02/26/2022
• Device Model Number: 6170
• Device Catalogue Number: 6170
• Device Lot Number: 7414848
• 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: 09/09/2021
• Supplement Date Received by Manufacturer: 09/23/2021; 10/11/2021; 11/09/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 09/29/2021; 10/28/2021; 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2020
• 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 LEAD; DBS LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 80 KG