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 Problem Seizures (2063)

Event Date 03/28/2019

Event Type  Injury  

Event Description

It was reported that the patient was admitted to the hospital due to an increase in seizures and they wanted somebody to check the patient's vns.The physician reported that diagnostics were determined to be within normal limits.No further relevant information has been received to date.

Event Description

Through a programming history review, it was found that a high impedance event associated with the m1000 firmware was found to have occurred at the same time of the patient's increased seizures.This high impedance is not expected to impact vns performance and so is not believed to be related to the patient's increased seizures.This event is captured mfr report # 1644487-2020-00909.

• Brand Name: PULSE GEN MODEL 1000
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 8542294
• MDR Text Key: 142860630
• Report Number: 1644487-2019-00765
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/30/2020
• Device Model Number: 1000
• Device Lot Number: 204646
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR