MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Weakness (1967); Nausea (1970); Blurred Vision (2137)

Event Date 03/03/2022

Event Type  Injury  

Event Description

The patient reported experiencing nausea, changes in vision, weakness, numbness, jerky movements, loss of consciousness, convulsions, and shakiness attributed to the vns.All of these events were reported to be very severe and constant by the patient.The vns settings were adjusted, and the patient was referred for vns battery replacement due to low battery.No known relevant surgical intervention has occurred to date.No additional relevant information has been received to date.

Manufacturer Narrative

Health effect: clinical code: (b)(4), health effect: clinical code: (b)(4), health effect: clinical code: (b)(4), health effect: clinical code: (b)(4), health effect: clinical code: (b)(4).

Event Description

The patient underwent prophylactic generator replacement.The explant facility is known not to return explanted devices.No additional relevant information has been received to date.

Event Description

Information was received that the adverse events were not reported by the patient at evaluation.The patient has anxiety issues not related to vns.

• Brand Name: PULSE GEN MODEL 105
• Type of Device: 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: 14018445
• MDR Text Key: 288783019
• Report Number: 1644487-2022-00393
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750054
• UDI-Public: 05425025750054
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2022

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/12/2019
• Device Model Number: 105
• Device Lot Number: 204306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/14/2022
• Initial Date FDA Received: 04/05/2022
• Supplement Dates Manufacturer Received: 04/06/2022; 04/15/2022
• Supplement Dates FDA Received: 04/14/2022; 05/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female