MAUDE Adverse Event Report: CYBERONICS, INC. VNS THERAPY DEMIPULSE; AUTONOMIC NERVE STIMULATOR

Model Number 103

Device Problems High impedance (1291); Nonstandard Device (1420); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Pain (1994); Seizures (2063); Electric Shock (2554)

Event Date 07/14/2014

Event Type  Injury  

Event Description

My client had a vagal nerve stimulator (vns) implanted on (b)(6) 2012 in hopes that it would eliminate or reduce the painful and debilitating grand mal seizures that she was having on a very consistent basis.Following implantation of the vns, her seizures became more frequent and more severe, but she held out hope that this would eventually turn around.It did not, and in face, became more threatening.On (b)(6) 2014, she experienced severe internal shocks that were painful and strong enough to drop her to the ground.She went to the hospital for treatment and it was discovered that she could not shut the vns down with the prescribed magnetic method and found no answer to why she was shocked.She was told by the manufacturer's representative that she should leave the vns in her body and that the voltage would be lowered from 2.25 ma to 0.75 ma to reduce the severity of the shock, if it were to happen again.She was told that if it shocked her again at this voltage it would hurt her less.Reducing the voltage did not work.She was again shocked in (b)(6) 2016 and again went to the hospital for treatment.She decided to have the vns shut off at the time and decided to have it surgically removed at the first available opportunity.Following the second shock in (b)(6) 2016, she was informed that "high ohms lead impedance" was detected from the vns but did not receive any other diagnosis concerning why she was being shocked or what the problem with the device might be.She was also not given any information on why her seizures had not subsided and why she did not feel any better after implantation of the vns.She had the vns surgically removed on (b)(6) 2016 by dr.(b)(6) in (b)(6).Due to the proximity of parts of the device to nerves in her neck, a portion of the vns still remains inside of her.The manufacturer's representative recovered the portion of the vns that was removed and it is believed to be in the manufacturer's possession.She believes that tests are currently being run on the vns.Following the surgery to remove the vns, she found out that her particular vns device, model number 103, was on an active recall at the time that it was surgically implanted in her body.The recall was initiated for model number 103 on october 4, 2011 and was not terminated until december 4, 2012.Her vns model number 103 was surgically implanted on (b)(6) 2012.The recall indicates that there was a software design issue that caused unexpected intensive follow-up indicator messages when trying to interrogate a vns model number 103.The recall indicates that implanting facilities were contacted on may , 2011 and may 10, 2011 to remove product from the field that was not yet implanted.However, as of (b)(6) 2012, her device was not removed from the field and was implanted while it was on recall.Following the removal of the vns she has had no grand mal seizures and has had only three petit mal seizures, which numbers are markedly lower than those prior to implantation of the device.At the time of the device malfunction my client's medications were: citalopram 10mg; clobazam 10mg; lamotrigine 200mg; lorazepam 2mg; norethindrone 0.35mg; toprimate 200mg.

• Brand Name: VNS THERAPY DEMIPULSE
• Type of Device: AUTONOMIC NERVE STIMULATOR
• Manufacturer (Section D): CYBERONICS, INC.
• MDR Report Key: 5616228
• MDR Text Key: 44011334
• Report Number: MW5061955
• Device Sequence Number: 1
• Product Code: LYJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 103
• Device Lot Number: BATCH # 894050
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention
• Patient Age: 31 YR
• Patient Weight: 73