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 Problems Depression (2361); Unspecified Heart Problem (4454)

Event Date 04/16/2021

Event Type  malfunction  

Event Description

Clinical study patient was reported to be experiencing heart palpations and worsening depression.The events were reported to be ongoing and the patient is recovering.No additional relevant information has been received to date.

Event Description

It was reported that the heart palpations and worsening depression were noted to be probably related to vns stimulation.Patient had an additional titration visit.The severity of the events was noted to be moderate.It was noted the study patient was looking to withdraw from the clinical study due to the adverse events.No corrective action is required as no new cause or new harm has been established for patient or user.

Event Description

It was reported the worsening depression is ongoing and has not resolved.No additional relevant information has been received to date.

Manufacturer Narrative

B3 date of event, corrected data: initial report inadvertently listed the incorrect event date.

Event Description

It was reported that the patient required medication being administered.This event is not considered to be resolved.No other 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 11825673
• MDR Text Key: 250837719
• Report Number: 1644487-2021-00656
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/15/2022
• Device Model Number: 1000
• Device Lot Number: 6795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/21/2021
• Initial Date FDA Received: 05/14/2021
• Supplement Dates Manufacturer Received: 07/20/2021; 08/19/2021; 03/02/2022; 12/21/2022
• Supplement Dates FDA Received: 08/12/2021; 09/13/2021; 03/02/2022; 01/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2021
• 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 Age: 71 YR
• Patient Sex: Female