MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem High impedance (1291)

Patient Problems Arrhythmia (1721); Dysphagia/ Odynophagia (1815); Anxiety (2328)

Event Date 06/12/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Patient presented with high impedance and other adverse events and had their settings lowered and was referred for surgery.The other adverse events were noted to be jolts of stimulation that caused the patient anxiety and tachycardia and also the patient had difficulty swallowing.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Information was obtained indicating that the tachycardia that was reported was related to vns stimulation and resolved once the patient's settings were lowered.The patient had no prior cardiac events and the patient had no symptoms suggesting an arrhythmia prior to the event.No other relevant information has been received to date.

Event Description

Patient underwent generator replacement surgery.High impedance was observed again for the patient but the surgeon decided that a lead revision would be performed at a later date.The explanted generator has not been received by product analysis to date.No known surgical intervention has occurred to date with the lead.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10436959
• MDR Text Key: 203851675
• Report Number: 1644487-2020-01098
• Device Sequence Number: 1
• Product Code: LYJ
• 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,Followup
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/16/2015
• Device Model Number: 102
• Device Lot Number: 202803
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/29/2020
• Initial Date FDA Received: 08/21/2020
• Supplement Dates Manufacturer Received: 09/02/2020; 03/12/2021
• Supplement Dates FDA Received: 09/25/2020; 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR