MAUDE Adverse Event Report: MICROTRANSPONDER INC. MICROTRANSPONDER® VIVISTIM® PAIRED VNS¿ SYSTEM (VIVISTIM® SYSTEM)

Model Number	MODEL 3000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Paresis (1998); Cough (4457)
Date of Event	06/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported coughing, hoarseness and difficulty having conversations post implant.The patient followed up with implanting physician and consulted a voice disorder specialist.Per the patient, they had vocal cord filler and symptoms have improved.Device history records were reviewed for ipg s/n (b)(6) and lead s/n (b)(6).The devices passed all functional specifications and quality tests and were sterilized prior to distribution.No other relevant information has been received to date.

• Brand Name: MICROTRANSPONDER® VIVISTIM® PAIRED VNS¿ SYSTEM (VIVISTIM® SYSTEM)
• Common Device Name: VIVISTIM® SYSTEM
• Manufacturer (Section D): MICROTRANSPONDER INC.; 2802 flintrock trace; suite 226; austin TX 78738
• Manufacturer Contact: brent tarver ; 2802 flintrock trace; suite 226; austin 78738
• MDR Report Key: 17380118
• Report Number: 3012309950-2023-00002
• Device Sequence Number: 6118382
• Product Code: QPY
• UDI-Device Identifier: 10810041430066
• UDI-Public: 10810041430066
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P210007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2023

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: 05/30/2023
• Device Model Number: MODEL 3000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female