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

Model Number 103

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

Patient Problem Asystole (4442)

Event Date 04/18/2023

Event Type  Death  

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 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 the patient was in the hospital and had atrial fibrillation.A cardioversion was performed without consulting vns precautions.Following the cardioversion, the patient became bradycardic and hypotensive, and complained of neck and jaw pain.Narcan was administered, and the patient¿s blood pressure improved.Twenty minutes later, the patient started to deteriorate again, and was transferred to the intensive care unit (icu).The patient was put on vasopressors and was stable.Hours later, the patient deteriorated again.Since they were do not resuscitate (dnr), cpr was not performed, but epinephrine was administered, improving their pulse.The patient passed away minutes later.Since this occurred within 12 hours of having a cardioversion, it was determined an unexpected death.The patient¿s physician later reported that the cause of neck and jaw pain was related to the presence of vns.The patient had a palpable muscle spasm along the left sternocleidomastoid (scm) muscle after their cardioversion in the icu.The hypotension was not related to vns but related to the sedation, cardiovascular medications, and patient¿s anemia.The atrial fibrillation was present on admission on 3/23, 3/28, and (b)(6) 2023.The last occurrence was post mechanical fall.The bradycardia was related to the amiodarone plus medication.The physician notes the cause of death was asystole.The patient was ¿do not resuscitate (dnr) so no attempts at transcutaneous or transvenous temp pacing were performed.The physician could not say for sure whether the death was related to vns since the patient had both acute and chronic respiratory and cardiovascular conditions that increases her risk.They cannot exclude vns as a contributing factor after the cardioversion.No other relevant information has been received to date.

Event Description

It was later reported that the initial reporter also submitted a report to the fda.

• Brand Name: PULSE GEN MODEL 103
• 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: 16963214
• MDR Text Key: 315580521
• Report Number: 1644487-2023-00643
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/18/2013
• Device Model Number: 103
• Device Lot Number: 3213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2011
• 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): Death
• Patient Age: 74 YR
• Patient Sex: Female