MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

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

Patient Problem Seizures (2063)

Event Date 11/01/2017

Event Type  malfunction  

Event Description

The patient reported that they are having very frequent "black outs" but is unsure if they are seizures or not.The patient has indoor cameras and when reviewed , there is no outward appearance of seizures, but it was stated that they just appear to be dead on camera, and the patient's latest blackout lasted for several days.The patient recently had a fall during one of the blackouts.The patient stated that the vns has never helped her.Additional information was received from the patient's previous neurologist who stated that they have not seen the patient since 2014, and there was no mention previously of the patient's black out events.It was stated that there is mention in the notes that the patient's vns stimulation was increased in (b)(6) 2013.It was stated that they didn't have any additional information.The patient reported that they have not seen a neurologist in over 3 years, and is currently only seeing their pcp.The patient is experiencing an increase in seizures which was described as dropping back as though dead where the patient is unconscious.The patient stated that she recently went to the er in response to one of these seizures.No other relevant information has been received to date.

Event Description

It was reported from the patient¿s primary care physician¿s office that this patient is in need of a vns generator replacement.It was stated that the patient was having problems back in (b)(6) as well as stating that the patient is now having difficulties with the vns.No known surgical intervention has occurred to date.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• 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: 7792799
• MDR Text Key: 117442902
• Report Number: 1644487-2018-01424
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/13/2014
• Device Model Number: 103
• Device Lot Number: 3540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 02/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 50 YR