MAUDE Adverse Event Report: LIVANOVA USA, INC. SYMMETRY GEN MODEL 8103; GENERATOR

Model Number	8103
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Headache (1880); Unspecified Heart Problem (4454)
Date of Event	10/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported experiencing a ringing in his head immediately following vns implant surgery.It was reported that the ringing did not change when stimulation was enabled/adjusted.The patient also reported heart effects and shortness of breath.The patient described that he could feel where his heart was in his chest and that it felt like the size of his fist.When the vns was disabled these side effects resolved.The patient has been referred for vns explant due to these adverse events.No known relevant surgical intervention has occurred to date.No additional relevant information has been received to date.
Event or Problem Description
Per the physician, the ringing in the head is not related to vns, and the shortness of breath and the cardiac issues are related to vns stimulation.No additional relevant information has been received to date.

• Brand Name: SYMMETRY GEN MODEL 8103
• Common Device Name: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 13904773
• Report Number: 1644487-2022-00330
• Device Sequence Number: 17260747
• Product Code: LYJ
• UDI-Device Identifier: 05425025750511
• UDI-Public: 05425025750511
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2022

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: 01/12/2022
• Device Model Number: 8103
• Device Lot Number: 205219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 61 YR
• Patient Sex: Female