MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 7103; GENERATOR

Model Number 7103

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Cardiac Arrest (1762)

Event Date 09/13/2022

Event Type  Injury  

Manufacturer Narrative

Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.

Event Description

It was reported that patient was experiencing an episodic high degree ac block possibly related to stimulation.A halter monitor showed an episodic high degree av block.This event is noted as a severe and serious adverse event since it required hospitalization.The hospitalization records noted that during hospitalization the subject had episodes of av block on telemetry and appeared that the vns was activating prior to episodes of bradycardia and av block.Also, many of the episodes occurred during the night as well and it was concluded that the untreated obstructive sleep apnea (osa) was likely contributing to increased vagal tone and exacerbating the av block.The subject¿s vns was turned off and still had one additional episode of av block noted on the telemetry.It is noted as also possibly related to underlying disease since conduction disturbances often occur in patients with heart failure.No other intervention was taken for the event.No other relevant information has been received to date.

Event Description

Further details were learned when hospital notes were reviewed.The patient was advised to present to the hospital when review of holter monitor he was wearing as part of research protocol showed intermittent second-degree type ii heart block.Patient had a total of 3 av block episodes of longer than 3 seconds.He was not symptomatic.He continued to have episodes of av block on telemetry while admitted.His av block is likely due to increased vagal tone.It appears his vns was activating prior to his episodes of bradycardia and av block.Many of his episodes occurred during the night as well and it is likely that untreated osa is continuing to his increased vagal tone and exacerbating the av block.His vns was turned off on (b)(4) 2022.He had one additional episode of av block noted on telemetry after vns was turned off.Av block observed during overnight polysomnogram as well.Patient was asymptomatic during event and denied chest pain, worsening shortness of breath, or presyncope.While in the hospital, patient had ecgs and x-rays.Although the patient had an av block event after the disablement of the vns, the vagus nerve could have lingering effects from the last stimulation received.The outcome of this event is the patient has recovered and event has resolved.X-rays have not been reviewed by manufacturer to date.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 7103
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 15673220
• MDR Text Key: 302421271
• Report Number: 1644487-2022-01330
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2022

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: 04/30/2022
• Device Model Number: 7103
• Device Lot Number: 205309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/04/2022
• Initial Date FDA Received: 10/26/2022
• Supplement Dates Manufacturer Received: 10/26/2022
• Supplement Dates FDA Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2020
• 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
• Patient Age: 60 YR
• Patient Sex: Male