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

Model Number 103

Device Problem Insufficient Information (3190)

Patient Problems Arrhythmia (1721); Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Undesired Nerve Stimulation (1980); Seizures (2063); Injury (2348); Loss Of Pulse (2562); Pericardial Effusion (3271)

Event Date 03/29/2016

Event Type  Injury  

Event Description

It was reported that a patient had laparoscopic nissun fundoplication surgery on (b)(6) 2016.Postoperatively, the patient was complicated by a seizure and then had cardioversion at 125j for arrhythmia.A ct scan was obtained, which showed a pericardial effusion.The patient was then emergency transported to another hospital for exploration surgery.During the surgery, it was determined that there was a hole in the pericardium and a tear in an arterial branch of the circumflex coronary artery.The vns magnet was placed over the device during this surgery.After the reparative surgery, the patient experienced recurrent episodes of painful stimulation, bradycardia, drop in blood pressure, and asystole during vns stimulation.The patient's magnet was placed over the generator, but, due to the patient being morbidly obese, the skin where the magnet was taped would move and allow stimulation to occur.The patient then had a temporary pacemaker implanted, and the vns was programmed to 0ma on (b)(6) 2016.Diagnostics were performed, and the results were all within normal limits.The arrhythmias and painful stimulation no longer occurred after the device was programmed off.The physician planned to leave the device programmed off for a while and slowly reintroduce therapy after the patient stabilized.It was also reported that the patient had a history of mild bradycardia prior to this event.No further relevant information has been received to date.

Event Description

Data was received from 03/29/2016 and 03/30/2016.No anomalies were noted - the data indicated that the device was functioning within normal limits.It was observed that the impedance had dropped from 2674 ohms to 1419 ohms (-47.0% change) on (b)(6) 2016, 5:57:24 (estimated).The sudden temporary drop in impedance could be attributed to the nerve¿s response to injury (i.E.Expel of ionic endoneurial fluids from damaged nerve cells; an observed increase in this fluid via mri is often used as an indicator of nerve injury).It was found that electrical current from the external defibrillator (cardioversion equipment) can transfer through the generator and leads to the vagus nerve, where the resulting charge density and energy delivered to the nerve from the defibrillation is at levels considerably higher than what the nerve experiences with vns therapy, even at maximal settings.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, 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: 5598322
• MDR Text Key: 43510228
• Report Number: 1644487-2016-00865
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2016

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: Lay User/Patient
• Device Expiration Date: 09/30/2015
• Device Model Number: 103
• Device Lot Number: 3773
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/29/2016
• Initial Date FDA Received: 04/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2013
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 51 YR