MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problems Dyspnea (1816); Muscle Weakness (1967); Seizures (2063)

Event Date 04/03/2020

Event Type  Injury  

Event Description

It was reported by patient that she was experiencing troubling breathing not related to stimulation.Additional information was received that the dyspnea was being caused by the vns causing an increase in seizures and leg muscle weakness.Intervention was taken in the form of a settings adjustment.No additional relevant information has been received to date.

Event Description

Additional information was received from the physician that the setting adjustment was for increase in seizures and muscle weakness to preclude serious injury.The physician noted there were other external factors that could be causing the increase in seizures and the increase in seizures were at the patient's pre-vns baseline.The cause of the muscle weakness is still unknown and the dyspnea reported is not related to increase in seizures and muscle weakness.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10077694
• MDR Text Key: 191662583
• Report Number: 1644487-2020-00729
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 06/19/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/09/2017
• Device Model Number: 106
• Device Lot Number: 203688
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 04/30/2020
• Initial Date FDA Received: 05/20/2020
• Supplement Dates Manufacturer Received: 05/29/2020
• Supplement Dates FDA Received: 06/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR