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 Dysphagia/ Odynophagia (1815); Edema (1820); Seizures (2063)

Event Date 12/17/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient was hospitalized due to difficulty swallowing.The patient has since been discharged and is doing better.The physician believed that the difficulty swallowing was most likely the result of anesthesia and intubation during vns surgery.Clinic notes were received dated 12/31/2018.After the patient¿s generator was replaced, the patient was admitted to the hospital due to vomiting and gagging and remained hospitalized for 11 days.The patient had an increase in seizures and severe constipation as well.Per the physician's assessment, the patient had a similar response to t&a so it is unknown if this was due to anesthesia or due to swelling in the neck following surgery.Attempts were made to the physician for more information.Per the physician, the patient's increase in seizures was believed to be due to missing medications due to vomiting.The increase in seizures was above pre vns baseline.The cause of the vomiting was unknown if it was due to constipation/discomfort from vns surgery/presumed neck swelling.The anesthesia and medications may have also contributed.The vomiting started the day after vns surgery.The patient had improved as quickly as it began.The constipation was a chronic condition that was made worse by surgery, likely due to anesthesia and was unrelated to the vns.The patient's swelling was only presumed based on symptoms.The swelling of the neck was from the vns surgery and began on the day of the vns surgery.The device history records were reviewed for the generator and lead.They passed all specifications prior to distribution.No additional information has been received to date.

Manufacturer Narrative

(b)(4).

• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8272311
• MDR Text Key: 133908971
• Report Number: 1644487-2019-00114
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2020
• Device Model Number: 1000
• Device Lot Number: 204625
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 1 MO
• Event Location: Other
• Date Manufacturer Received: 09/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2018
• 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): Hospitalization
• Patient Age: 6 YR