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 04/26/2018

Event Type  Injury  

Event Description

It was reported that the patient has had an increase in seizures following their vns replacement.The physician did not know the cause of the increase in seizures, and the patient had been titrated to their previous generator settings.The increase in seizures was above pre-vns baseline frequency.The patient¿s current settings and diagnostics are unknown, although the last diagnostic test was reported to be within normal limits.No surgical intervention has occurred to date.No additional information has been received to date.

Event Description

The generator was replaced due to prophylactic replacement.The explanting facility historically does not return devices, so the generator has not been returned to date.No additional or relevant information has been received.

• 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: 8330976
• MDR Text Key: 135865189
• Report Number: 1644487-2019-00264
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/18/2020
• Device Model Number: 1000
• Device Lot Number: 5688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: 9 MO
• Event Location: Other
• Date Manufacturer Received: 02/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2018
• 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): Required Intervention
• Patient Age: 31 YR