MAUDE Adverse Event Report: CYBERONICS / LIVANOVA USA, INC. VAGEL NERVE STIMULATOR (VNS) PERENNIAL FLEX LEAD; STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY

Model Number LEAD MODEL 402

Device Problem Break (1069)

Patient Problems Atrial Fibrillation (1729); Bradycardia (1751); Fall (1848); Bone Fracture(s) (1870); Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Neck Pain (2433); Diminished Pulse Pressure (2606)

Event Date 04/19/2023

Event Type  Death  

Event Description

Patient presented to the emergency department after she became dizzy and fell at home landing on her right wrist and side.Imaging indicated a fracture of the right distal radius, ct head/c-spine and x-ray right shoulder were negative.Ekg revealed atrial fibrillation with rvr.Patient was admitted for further monitoring of a-fib and ortho consulted for management of the wrist fracture.Cardiology consulted and started patient on oral amiodarone.Patient continued in a-fib the following day and cardiology recommended a tee cardioversion completed on (b)(6) 2023 at 1400.Following the cardioversion, patient became bradycardic and hypotensive, narcan was administered which improved the blood pressure.Patient became hypotensive again 20 minutes later, complaining of jaw/neck pain, rapid response was called, and patient was transferred to icu and started on pressors.Patient became more bradycardic overnight and eventually lost pulses and expired.Patient was a dnr/dni at admission.Epinephrine was administered when patient became pulseless but unable to achieve rosc.Facility is unable to conclude the cause of death with this patient.Facility is questioning the possibility of damage to the vagus nerve stimulator from the cardioversion and has notified the manufacturer for further follow-up and investigation.Reference report #mw5117132.

• Brand Name: VAGEL NERVE STIMULATOR (VNS) PERENNIAL FLEX LEAD
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): CYBERONICS / LIVANOVA USA, INC.
• MDR Report Key: 16843388
• MDR Text Key: 314402045
• Report Number: MW5117133
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LEAD MODEL 402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 74 YR
• Patient Sex: Female