MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 303

Model Number	303-20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Paralysis (1997)
Date of Event	09/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Report was received from the patient's psychiatrist that the patient has undergone various vns surgeries, however not all have been confirmed to have occurred.One of the recent surgeries mentioned was due to a lead issue which has been reported in mfr.Report #1644487-2019-01733.It was indicated that the patient has a paralyzed vocal cord however at this time it is unknown whether this is related to any of the vns surgeries.No additional relevant information has been received to date.
Event or Problem Description
Additional information was received from the physician's office that the vocal cord paralysis was discovered following surgery per the patient.The vocal cord paralysis is indicated to be due to surgery and the hoarseness began after the surgery before stimulation was turned on.It was indicated that the patient has only had 2 vns surgeries.Based on when the event was reported and when the last surgery occurred, it is likely the reported vocal cord paralysis was related to the revision surgery that occurred due to the lead issue reported in mfr.Report #1644487-2019-01733.Last programmed settings and diagnostics were provided.No additional relevant information has been received to date.

• Brand Name: LEAD MODEL 303
• Common Device Name: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 9362398
• Report Number: 1644487-2019-02284
• Device Sequence Number: 11394234
• Product Code: LYJ
• UDI-Device Identifier: 05425025750122
• UDI-Public: 05425025750122
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2020

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: 01/31/2021
• Device Model Number: 303-20
• Device Lot Number: 204006
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 01/06/2020
• 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: Disability
• Patient Age: 72 YR