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 06/15/2019

Event Type  Injury  

Event Description

It was reported that the patient experienced changes in hear rate related to the vns.It was reported that the patient experienced tachycardia, their heart rate prior to the event was reportedly 70 bpm and the heart rate during the event was approximately 200 bpm.It was reported that the patient experienced palpitations and that there were no traumatic events or triggers prior to the arrhythmia.The event did not follow a medication change, device diagnostics test, a settings change or with the on time of the vns.The neurologist assessed that the tachycardia was not related to vns therapy stimulation; however, it was indicated that the vns exacerbated or co-currently contributed to the arrhythmia.The patient's generator was disabled due to the tachycardia experienced but the neurologist reported this was not performed to preclude a serious injury.The patient's neurologist reported that the patient had a prior history of cardiac events including cardiac dysrhythmia and bradycardia.No further relevant information has been received to date.

Manufacturer Narrative

(b)(4).

• 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: 8780203
• MDR Text Key: 150688259
• Report Number: 1644487-2019-01343
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/05/2021
• Device Model Number: 1000
• Device Lot Number: 204895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2019
• 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): Other
• Patient Age: 45 YR