MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

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

Patient Problem Arrhythmia (1721)

Event Date 11/03/2020

Event Type  Injury  

Event Description

It was reported through a clinical study that a patient experienced and recovered from cardiorespiratory arrest.The event was noted as not related to the implant procedure but possibly related to vns stimulation.Start date was (b)(6) 2020 and date of first stimulation was (b)(6) 2020.The patient was implanted (b)(6) 2020.Medical intervention to preclude a serious injury was taken.The patient was admitted to the hospital (b)(6) 2020 to (b)(6) 2020.The patient's vns treatment was interrupted as a result of this event.Information was received from the physician and clinic notes regarding the patient's reported cardiopulmonary arrest.It was reported that the patient's vns was implanted and turned on.There were no cardiovascular abnormalities during the procedure.Later that day (approximately 7 hours later), the patient presented with oxygen desaturation of 88% and bradycardia.The bradycardia progressed to until disappearance of valid peripheral pulse/ cardiac arrest and further desaturation to 20% oxygen saturation.3 cycles of cpr were required to resuscitate the patient.Anesthesiologic evaluation was performed without indication for intensive care admission and the vns was switched off.3 days later, the vns was switched on to the same output current as before and then turned back off with the holter monitor findings normal while vns stimulation was on and off.3 days later he vns was switched on again without clinical problems.The patient was then discharged from the hospital with the vns on.The doctor believed that the cardiac arrest may be related to the vns stimulation due to the temporal correlation of the event with vns implantation and activation.However, he also believed it was probably related to the patients' clinical condition based on the patient having previous desaturation events (caused by crying or due to seizures).Of note the patient had a similar episode at (b)(6) months old (and the patient is now (b)(6) years old.) the manufacturer's device history records of the patient's m1000 were reviewed and the generator passed final functional and quality specifications prior to release.No device malfunction was reported.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 1000
• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 10992220
• MDR Text Key: 220940945
• Report Number: 1644487-2020-01659
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2020

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: 08/20/2021
• Device Model Number: 1000
• Device Lot Number: 6443
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/11/2020
• Date Device Manufactured: 10/21/2019
• 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; Required Intervention
• Patient Age: 3 YR