MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

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

Patient Problems Seizures (2063); Sleep Dysfunction (2517); Cognitive Changes (2551)

Event Date 09/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient was admitted into the hospital due to a report of increased seizures, extreme pain, the patient not being able to eat and can only sleep sitting up due to a choking sensation and also there were changes to the patient's mental status.It was noted that the patient experienced a fall which is expected to have caused the generator to shift causing a lead pulling sensation.X-rays and ct scans were performed but the physician could not determine the cause of the patient's events from the scans.The device was disabled, but the patient is still dealing with the same adverse events so the patient's mother wants to have the device explanted.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Information obtained through the patient's mother that it was assessed that the patient's reported issues were not being caused by the vns.It was determined that the patient had a severe bladder infection which was the root cause of the patient's issues, so the patient's device was turned back on and titrated up over a period of time.No other relevant information has been received to date.

Manufacturer Narrative

Evaluation codes, corrected data: initial report inadvertently left out applicable method codes.

Event Description

Additional information was received noting that the patient has been experiencing an increase in seizures due to their vns battery being depleted.Patient underwent generator replacement surgery.The explanted generator was discarded.

• Brand Name: PULSE GEN MODEL 105
• 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: 10823634
• MDR Text Key: 215887648
• Report Number: 1644487-2020-01510
• Device Sequence Number: 1
• Product Code: LYJ
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/28/2022

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: 08/08/2016
• Device Model Number: 105
• Device Lot Number: 4064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/17/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 11/18/2020; 01/04/2022
• Supplement Dates FDA Received: 12/09/2020; 01/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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: 29 YR
• Patient Sex: Male