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 Problem Seizures (2063)

Event Date 01/28/2019

Event Type  malfunction  

Event Description

It was reported that the patient could no longer feel their device stimulation and that the patient experienced an increase in seizure frequency that caused the staff at the patient's nursing home to believe the vns was no longer working.The patient's neurologist indicated that the patient goes through "ups and downs" with seizure frequency and has potential non-epileptic seizures so the physician was unable to tell if the patient's current state was an increase in seizures.The neurologist indicated that the patient's vns settings had been consistent, and that the increase in seizures was likely not related to a change in vns settings.The neurologist indicated the patient's medications had recently changed and the patient had moved to a nursing home in (b)(6) of 2018.The patient's nursing home indicated that they wanted the patient to be replaced prophylactically for the responsive stimulation feature.No known relevant surgical intervention has occurred to date.No further relevant information has been received to date.

Event Description

It was reported that the patient underwent a generator replacement.It was reported that the facility discards explanted products and therefore return of the suspect product is not expected to date.No further relevant information has been received to date.

• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8362978
• MDR Text Key: 136906255
• Report Number: 1644487-2019-00345
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750054
• UDI-Public: 05425025750054
• 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: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/08/2016
• Device Model Number: 105
• Device Lot Number: 203230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2015
• 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 Age: 40 YR