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 Headache (1880); Seizures (2063); Cognitive Changes (2551)

Event Date 10/26/2020

Event Type  Injury  

Event Description

It was reported via clinic notes that the patient's father feels like the patient's seizures are a little worse and migraines have increased and the patient has trouble focusing.It was reported that the vns battery seems low.No surgical intervention has been reported to date.No additional relevant information has been received to date.

Event Description

The patient had a battery replacement procedure.The explanted device is available for return but has not been received to date.No other relevant information has been received to date.

Manufacturer Narrative

D.6b.If explanted, give date (mo/day/yr), f.10.Health effect ¿ impact code; initial and supplemental mdr inadvertently omitted information known prior to submission.

Event Description

The battery replacement procedure reported in the supplemental report was not on the suspect device.The suspect device was explanted on (b)(6) 2021 which was not included in the initial report in error.The device is now assumed to be discarded.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: 11252370
• MDR Text Key: 229439110
• Report Number: 1644487-2021-00122
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/18/2020
• Device Model Number: 1000
• Device Lot Number: 204771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2019
• 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): Required Intervention
• Patient Age: 30 YR
• Patient Sex: Male