MAUDE Adverse Event Report: LIVANOVA USA, INC. BIPOL LEAD MODEL 300

Model Number 302-20

Device Problems Fracture (1260); High impedance (1291)

Patient Problems Nerve Damage (1979); Paralysis (1997); Paresis (1998); Choking (2464); Cough (4457)

Event Date 12/22/2020

Event Type  malfunction  

Event Description

It was stated that prior to surgery for a routine battery replacement, high impedance was observed.Surgery was performed to revision lead and replace the generator.While explanting existing electrodes, the surgeon noted the left vagus nerve was found to be too attenuated (weakened).Surgeon did not continue with implanting the vns system.The explanted devices were discarded.The patient is set to be reevaluated by the surgeon before being reimplanted.Per the physician, the patient was first observed to have high impedance during check on 12/22/2020.No additional relevant information has been received.

Manufacturer Narrative

F10.Health effect - clinical code - codes e2402 were used to house the report of facial flushing and puffy eyes.F10.Component code - correction - code a040101 should have in place of code a072201 in the initial mdr.H6.Investigation findings - correction - code c070603 should have in place of code c0203 in the initial mdr.H6.Investigation conclusions - correction - code d02 should have in place of code d15 in the initial mdr.Health effect - clinical code :e2402.Health effect - clinical code :e2402.

Event Description

It was reported the patient was seen in the emergency room on (b)(6) 2021 due to dysphagia, coughing, voice alteration, and facial flushing.Patient was referred to an ent.Per surgical notes, the left vagal nerve was "eroded".Per ent, on the left ipsilateral to the side of the stimulator, there appears to be some time in the vocal cord.The cord appears to be paretic (partial paralysis), but is not full paralyzed.The patient was hospitalized for investigation and ent assessment of the events.Per the neurologist, the dysphagia, coughing and voice alteration are related to the abnormality seen in the nerve.The cause of the facial flushing/puffy eyes was not able to be provided.The event had resolved.No additional relevant information has been received to date.

Manufacturer Narrative

B5.Describe event or problem - correction - "there appears to be some tone in the vocal cord" was incorrectly included in supplemental #1 mdr.F6.Health effect - clinical code - correction - code e012204 was inadvertently reported in the supplemental #1 mdr.

Event Description

Ent is proposing to fix the patient's vocal cord paresis with a common procedure.Once healed, the plan would be to implant new vns electrodes superior to the original location.Surgeon provided additional information regarding what was observed in surgery.Per the provider, the nerve was thinned out just above the proximal electrode and did not believe the nerve would structurally hold the new electrodes.No additional relevant information has been received.

• Brand Name: BIPOL LEAD MODEL 300
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 12263544
• MDR Text Key: 264713033
• Report Number: 1644487-2021-01049
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2018
• Device Model Number: 302-20
• Device Lot Number: 203008
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/08/2021
• Initial Date FDA Received: 08/02/2021
• Supplement Dates Manufacturer Received: 08/30/2021; 09/28/2021
• Supplement Dates FDA Received: 09/24/2021; 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 20 YR