MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 303

Model Number	303-30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Paresis (1998)
Date of Event	03/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was experiencing a sensation of dyspnea while speaking and hoarseness.When seen by otolaryngology, it was noted that the patient has left vocal paresis and had an injection in the vocal fold.It was stated that the patient has had previous neck trauma and had to be trached after an accident due to a seizure, prior to vns placement.No additional relevant information has been received to date.
Additional Manufacturer Narrative
Age at time of event, corrected data: follow-up report #1 inadvertently did not update the field to "(b)(6)".
Event or Problem Description
Follow up with the medical professional's office revealed that the dyspnea and hoarseness were due to the patient yelling at her dog.The adverse events occurred with and were exacerbated by vns stimulation.The reported vocal cord paresis was related to the patient yelling at her dog.It was unknown if the paresis was temporary.

• Brand Name: LEAD MODEL 303
• Common Device Name: LEAD
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 8732750
• Report Number: 1644487-2019-01207
• Device Sequence Number: 14071496
• Product Code: LYJ
• UDI-Device Identifier: 05425025750122
• UDI-Public: 05425025750122
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2019

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: Lay User/Patient
• Device Expiration Date: 09/12/2021
• Device Model Number: 303-30
• Device Lot Number: 204336
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Received by Manufacturer: 06/01/2019
• Supplement Date Received by Manufacturer: 08/01/2019; 09/18/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 08/26/2019; 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR