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 Problems Depression (2361); No Code Available (3191)

Event Date 10/16/2017

Event Type  Injury  

Event Description

It was reported that this patient has had an increase in depression that is about as bad as it was before vns therapy.The patient's depression got much worse and therefore they admitted themselves into a psych unit.Due to the increase in depression the patient was referred to a surgeon for replacement.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

It was reported that this patient's generator was replaced, and the explanted generator was discarded after surgery.No other relevant information has been received to date.

Event Description

Further information was received noting that the patient had not known that their battery was completely depleted until they were in the hospital with suicidal thoughts, depression, and thoughts of killing themselves.It was observed that the battery was depleted.No other 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: 7046139
• MDR Text Key: 92535999
• Report Number: 1644487-2017-04834
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/22/2019

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: 08/19/2015
• Device Model Number: 102
• Device Lot Number: 202670
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/27/2017
• Initial Date FDA Received: 11/20/2017
• Supplement Dates Manufacturer Received: 11/30/2017; 10/30/2019
• Supplement Dates FDA Received: 12/14/2017; 11/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2013
• 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): Required Intervention
• Patient Age: 59 YR