MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problems Dysphagia/ Odynophagia (1815); Seizures (2063); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/25/2016

Event Type  Injury  

Event Description

It was reported from a post on social media on (b)(6) 2017, that the patient states that vns did not work for her and that she was having more seizures so the device was turned off.It was reported by the physician that the patient used to have 1 to 2 generalized tonic-clonic (gtcs) seizures per year and the seizures were preceded by auras/focal seizures.After vns, she does not have gtcs but started to have 1 to 2 auras and focal seizures per month.Patient preferred to have 1-2 gtcs over 1-2 aura/focal seizures a month.No additional relevant information has been received to date.

Event Description

The patient posted again on social media that she had her vns turned off because it was causing her more problems than she had previously.However, she also reported that she has control now because when she feels like she is going to have a seizure she swipes the magnet.It appears from this post that the patient¿s magnet output current is not disabled.No additional of relevant information has been received to date.

Event Description

It was later reported that patient is referred for explant.The explant reason was not explicitly stated.The clinic notes state previous disablement due to increased seizure activity that is not presently occurring.Magnet stimulation is still enabled but seldom used.It is noted that when normal therapy was enabled she has auras that won't stop.Further information was received from patient who reported that she had troubles swallowing and went to an otolaryngologist who opened he esophagus which helped but they were unsure if this was related to vns or not.She also reports she can feel the lead under her skin.Lead protrusion will be reported in mfr.Report # 1644487-2023-01138.Patient also states the implant (assumed generator) moves around and can be turned on its side.States after speaking with the neurologist they feel its time to get it removed.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 6956002
• MDR Text Key: 89540868
• Report Number: 1644487-2017-04628
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: Other,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2017
• Device Model Number: 106
• Device Lot Number: 203655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2015
• 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 Outcome(s): Required Intervention; Other
• Patient Age: 53 YR
• Patient Sex: Female