MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL UNKNOWN

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems Bradycardia (1751); Dysphagia/ Odynophagia (1815); Pain (1994); Tissue Damage (2104); Injury (2348)

Event Date 02/25/2015

Event Type  Injury  

Event Description

Additional data was received and review of the programming/diagnostic history shows that the device is still functioning within normal limits.Additional information was received that the patient underwent the cardioversion procedure on (b)(6) 2015.There were no precautions taken during the procedure.A magnet was not used to disable it during the procedure as the operators thought the device was end of life.

Event Description

It was reported that the patient still experienced pain in neck area due to the cardioversion procedure.It was also mentioned that the vns therapy was working well for the patient until the cardioversion incident.The patient also underwent surgery on the throat and reported to have probably burnt his vocal cords.The physician mentioned the theory that the lead passed the energy to the nerve during the cardioversion procedure, which resulted in the patient's adverse events.Review of the programming and diagnostic data for this patient indicates that the impedance value was 2107 ohms on (b)(6) 2015 and has been consistently between 2100 and 2400 prior to cardioversion procedure.On (b)(6) 2015, the impedance value was 1350 ohms.The impedance value on (b)(6) 2015 is 1379 ohms.

Manufacturer Narrative

Review of the available programming and diagnostic history.

Event Description

It was reported that the patient experienced sharp painful stimulation every 90 seconds after undergoing an electrical cardioversion for atrial fibrillation with rapid ventricular rate.Prior to the cardioversion, patient had a transesophageal echocardiogram but was reported to be able to swallow without issues following this procedure.After the cardioversion, the patient was having significant and periodic bradycardic events with a heart rate drop from the high 90's into the 30's.Patient would simultaneously moan, bear down, and complain of severe neck pain.Once the vns was turned off, the events ceased.When a system diagnostic test was attempted, the patient again had bradycardia and the programming wand was quickly removed.I didn't think it wise to try that again.With the device off, the patient was tested with modified barium swallow and found to have a complete dysphagia.This test will likely be repeated within a few days to assess any improvement.It is unknown if the device was programmed off when the patient had the cardioversion procedure.X-rays were taken of the neck and there were no obvious anomalies identified in the images received.The physician believes there may be a micro fracture in the lead and stimulating the neck near the vagus nerve causing the pain that triggered a vagal response in a physiologic manner as opposed to via direct vagal stimulation.The physician is concerned that the patient now has a vagus neurapraxia due to electrical injury.It was also reported that there is no definitive way to test for this to be sure.Additional relevant information have not been received to date.

Event Description

Additional information was received that the patient still has pain despite vns being off.A report on the cardioversion procedure was also received stating that the procedure occurred on (b)(6) 2015 at 15:02.Synchronized bi-phasic cardioversion was performed with a medtronic lifespak 12 cardioversion device.Adhesive patches were used and 200j of energy was used to shock.The patient has a history of hypertension, a vns for seizure disorder, restless leg syndrome, and a new onset of atrial fibrillation.Echo findings showed no laa thrombus.The ejection fraction from the echo was 65%.During the procedure, the patient was brought to the electrophysiology lab in a fasting state after informed consent was obtained.Hemodynamic monitoring was established, and anesthesia was administered.Synchronized biphasic cardioversion was performed, the patient was reassessed, and the patient left the lab in a stable condition.Results showed that pre-rhythm was atrial defibrillation, and the post-rhythm was sinus.200j of energy was delivered externally.There were no noted complications, and the dc cardioversion was deemed successful.Clinical course was to be observed.

Event Description

An abstract written by the patient's physician was received on 12/10/2015.The abstract stated that the patient was admitted to the hospital for new-onset atrial fibrillation.Chemical cardioversion was attempted, but was unsuccessful.After being cleared with a tee for an intracardiac thrombus, the patient underwent dc cardioversion to sinus rhythm.Shortly after the dc cardioversion, the patient experienced persistent dysphagia and periodic (in synch with stimulation) throat irritation, dry hacking cough, and symptomatic bradycardia with heart rate dropping to the 20s.The periodic symptoms resolved after the device was deactivated with the magnet, but the patient remained dysphagic.On fluoroscopy for swallow evaluation, the vns leads could be seen exposed in the soft tissue of the neck.The physician believed that the patient's nerve was burned, which caused the persistent dysphagia, and that the vns lead was "naked" and was shocking the patient's neck soft tissue and causing the periodic issues.There were still no plans to replace the generator, as this would aggravate the patient's condition.

Event Description

The patient was referred for full revision surgery.No known surgery has occurred to-date.

Manufacturer Narrative

It was inadvertently not provided in follow-up report#6 that the surgery had occurred on (b)(6) 2016.The explant date of the device was inadvertently not provided.

Event Description

Full revision surgery occurred.The explant facility does not return devices to the manufacturer per policy, and it was reported the product may have been discarded.

Manufacturer Narrative

Date received by manufacturer: 12/20/2017.(b)(4).

Event Description

Additional information was received that the patient sustained damage to his vocal cords following a cardioversion procedure.

• Brand Name: LEAD MODEL UNKNOWN
• Type of Device: LEAD
• 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: 4618197
• MDR Text Key: 5951809
• Report Number: 1644487-2015-04178
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/18/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/01/2015
• Initial Date FDA Received: 03/19/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided; 11/21/2016; 01/17/2018
• Supplement Dates FDA Received: 05/11/2015; 07/22/2015; 01/04/2016; 11/21/2016; 12/16/2016; 12/27/2017; 01/17/2018
• 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: 60 YR