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 Diarrhea (1811); Seizures (2063); Weight Changes (2607); Decreased Appetite (4569)

Event Date 10/08/2020

Event Type  Injury  

Event Description

A patient reported that her seizures increased with vns, and that they got worse every time her settings were increased.She also said her seizure frequency decreased slightly after her device was disabled.No additional information has been received to date.

Event Description

Information was now received that the patient had their vns removed.It was noted the explant was related to their disablement which occurred in (b)(6) 2020 and related to nausea alleged against the vns however the physician in clinic notes from (b)(6) 2020, stated the nausea began prior to vns implantation and has gotten worse progressively.It was noted the patient also had decreased appetite, weight loss, and loose stool would be only typical for vns side effects.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: 10781800
• MDR Text Key: 214513711
• Report Number: 1644487-2020-01477
• 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
• Report Date: 07/12/2021

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: 04/26/2020
• Device Model Number: 106
• Device Lot Number: 204508
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 06/17/2021
• Supplement Dates FDA Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR