MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 104; GENERATOR

Model Number 104

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

Patient Problems Chest Pain (1776); Pain (1994); Seizures (2063); Tissue Damage (2104)

Event Date 09/05/2017

Event Type  Injury  

Event Description

It was reported by the patient that he has had more seizures.He clarified he is having fewer seizures than he did before the vns was implanted, but he is still concerned with the functionality of his current device.Per patient, the implanting surgeon "nicked his skin" during his implant surgery.Per surgeon, patient would be fine, but patient is concerned this may potentially be a cause of the increased seizures.Patient also stated he hasn't been able to feel the stimulation in his device since this implant, when he could feel stimulation on previous implants.Per neurologist's clinic notes, the patient said that he has had more auras and has to stimulate the vns more.Further, he said that the vns device has much pain and soreness around the area that he thinks that this is unusual.Patient also said that the injections in the inferior pectoralis major muscle/serratus posterior were not effective.Per the doctor, the patient still has tenderness and point pain around the vns device.

Event Description

Per surgeon's notes from the patient's consult, patient reported decreased seizures for the first 3 months following the implant.After that, he reported increasing pain at the battery site and over the last 3-4 months and increase in seizure activity.Patient reports auras and headaches as well as increase in seizures.Patient stated to surgeon that the surgeon"knicked" the skin during surgery.Per patient's wife, those were not the words that surgeon used.The surgeon has no recollection of this.But based on the notes from post op progress note, patient reported having a skin tear from the procedure which had since healed.The chest and neck incision were well healed.Moderate tenderness associated with the area of the generator without induration, redness, or any obvious soft tissue abnormality were noted.There was no evidence of infection.Patient's symptoms associated with pain and probably a certain extent increase in seizures started around 3 months after generator placement.The surgeon did not have any concerning findings.Surgeon discussed the possibility of placing the generator in a different area.The patient does not want to proceed with this.No known surgical interventions have occurred.Patient believes that the vns is not working right as he has seizures every month (2 this month), and has auras 3-4 times a day, and also experiences pain off and on every day and night.He says that the pain and seizures are getting hard for him and he wants to see if it is possible to have his implant fixed.

Event Description

Additional clinic notes were received, which indicate that the patient's keppra medication is low and is sub-therapeutic at 7.6 u/ml.The physician planned to increase keppra to 250 mg bid.However, the patient is convinced that the vns is malfunctioning and would rather have vns investigated than increase keppra.No additional relevant information has been received to date.

Event Description

Information was received that the patient's device does not need replacement at this time and that a setting adjustment was made.Device diagnostics were ok and patient did not have any adverse events.

• Brand Name: PULSE GEN MODEL 104
• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7774387
• MDR Text Key: 116851448
• Report Number: 1644487-2018-01377
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750047
• UDI-Public: 05425025750047
• 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,Followup,Followup
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/19/2018
• Device Model Number: 104
• Device Lot Number: 203778
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 11/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2016
• 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; Required Intervention
• Patient Age: 55 YR