MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

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

Patient Problems Anemia (1706); Sepsis (2067); Discomfort (2330); Gastrointestinal Hemorrhage (4476); Stomach Ulceration (4488)

Event Date 04/21/2022

Event Type  Injury  

Event Description

Neurologist reported that patient had implant two weeks ago and later she tolerated her setting adjustment.A week later she had abdominal pain and patient was found to have a perforated ulcer and abdominal bleeding.She was in office post-op and requested to have device turned off and removed.Her surgeon that did her gastric surgery told her ulcer was due to the vns stimulation and now the patient has made up her mind to have device removed.Neurologist states he does not know the surgeon or his knowledge on vns.Neurologist has turned device off and is monitoring patient.Patient's husband later reported that his wife had a stomach ulcer and was in the icu for a week because of her malfunctioning device.He said the patient will have trauma due to the effects of device and currently cannot work due to the malfunction.He was not made aware of any side effects other than voice alteration and mild cough prior to implant.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Patient husband later reported that the doctors could not find a solid conclusion to the cause of the ulcer, however the neurosurgeon and neurologist agreed that it was in relation to vns and said the device should be explanted.During the process of removing the ulcer his wife had a quarter sized hole between her colon and small intestine.Contents of her abdomen leaked into the hole and she ended up going septic.Patient was in the icu on a all liquid/soft food diet and it was noted that as soon as she returned to eating normally she experienced the shocking in her stomach again, which patient believes was caused by the vns.

Event Description

Patient's spouse later reported that no trauma or manipulation had occurred prior to the ulcer that could have attributed to this.He said that all the medical professionals attributed the ulcer to the vns device, ie surgeon, primary care provider, and neurologist.Because of all the surgeries, the patient's spouse mentioned the patient became anemic.He did say that since the surgeries there have been no more reports of pain from the device shocking; the patient abdomen nor has any further ulcers develop.He said that he thinks that the device overstimulated the vagal nerve and caused a buildup of acid in her stomach that caused the ulcer to develop.He said that at the time the device was programmed off provider did not indicate an diagnostic issues with the device nor that he suspected migration.

Event Description

Patient's husband later reported that the patient's stomach pain started immediately after turning the device on.It had previously been reported that this pain started a week following the start of stimulation.

Event Description

It was later reported that patient had their generator and lead explanted.The suspect product has not been received by manufacturer to date.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 1000
• 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: 14517162
• MDR Text Key: 292755580
• Report Number: 1644487-2022-00607
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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,Followup,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/22/2023
• Device Model Number: 1000
• Device Lot Number: 575
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2022
• 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; Hospitalization
• Patient Age: 33 YR
• Patient Sex: Male