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 Problems Anxiety (2328); Depression (2361)

Event Date 04/15/2020

Event Type  malfunction  

Event Description

It was reported that the patient was experiencing an exacerbation due to severe depressive episode and anxiety.It was noted that the relatedness to vns was not known.No additional relevant information has been received to date.

Event Description

It was reported that the exacerbation due to depressive episode and anxiety had a causal relationship to the patient's primary condition.It was noted that the patient had been hospitalized due to the adverse event.The relationship of the adverse events to vns stimulation was still noted as unknown.No additional relevant information has been received to date.

Event Description

It was reported that the patient medication dosage was changed and ect therapy was added.The event has not resolved.Patient was admitted on (b)(6) 2020 and discharged on (b)(6) 2020.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10319839
• MDR Text Key: 200220102
• Report Number: 1644487-2020-00989
• Device Sequence Number: 1
• Product Code: MUZ
• UDI-Device Identifier: 05425025750030
• UDI-Public: 05425025750030
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/02/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/08/2020
• Device Model Number: 103
• Device Lot Number: 204464
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/24/2020
• Supplement Dates Manufacturer Received: 06/23/2021; 08/11/2021
• Supplement Dates FDA Received: 06/30/2021; 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 62 YR