MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

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

Patient Problem Depression (2361)

Event Date 02/01/2016

Event Type  malfunction  

Event Description

It was reported that the patient was experiencing an increase in depression due to the vns being ¿non-functional¿ for the past three years.It was clarified that the vns was thought to be non-functional due to the increase in depression and the patient not perceiving stimulation.It was stated that the patient would perceive stimulation for a while after the vns was interrogated, programmed, or had diagnostics performed, but after a couple of days, the patient would no longer perceive stimulation.Follow up with the physician revealed that the vns was checked the previous year and no problems were identified with the device functionality.The surgeon had offered to replace the vns, but the patient declined replacement.The patient was seen again recently and the diagnostics were within normal limits.It was noted that the patient had pretty severe depression and dementia.The dementia was not attributed to the vns.No additional relevant information has been received to date.

Event Description

The patient underwent vns generator replacement surgery due to a near end of service = yes condition.During attempts at product return, it was revealed by the facility that they discard all explanted devices.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• 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: 8175410
• MDR Text Key: 130898401
• Report Number: 1644487-2018-02333
• Device Sequence Number: 1
• Product Code: MUZ
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/28/2010
• Device Model Number: 102
• Device Lot Number: 200948
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 10/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2008
• 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: 74 YR