MAUDE Adverse Event Report: 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	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Related manufacturer reference number: 1627487-2021-17062.It was reported that following an implant procedure on (b)(6) 2021, the patient experienced a mild subarachnoid hemorrhage at the left frontal sulcus.The patient was asymptomatic.No further information is known at this time.
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.

• Brand Name: 8CH INFINITY DBS LEAD KIT, 30CM, 0.5, B
• Common Device Name: DBS LEAD
• MDR Report Key: 12546517
• Report Number: 1627487-2021-17061
• Device Sequence Number: 5146757
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

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: 7414844
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/10/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 11/02/2021
• 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: 6172 DBS LEAD; 6172 DBS LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Weight: 75