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

Model Number 102

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 01/01/2014

Event Type  Injury  

Event Description

Clinic notes were received that indicated that the patient was having an increase in depression.He feels that his mood worsened with adjustment of his vns and has anger and manic episodes.His medications have not changed.Patient had threatened the life of his parents multiple time by holding a knife to their throats and then threatening to kill himself after he killed them.One time he was off of depakote at the time he threatened his parents.Other times he has threatened to kill them and others with no associated action.Attempts for additional information have been unsuccessful.

Manufacturer Narrative

Event Description

It was reported that the patient's device was partially disabled due to mood swings.No additional 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: 4204277
• MDR Text Key: 4979080
• Report Number: 1644487-2014-02845
• 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: Health Professional,company representative,hea
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

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: 07/31/2015
• Device Model Number: 102
• Device Lot Number: 3716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 10/01/2014
• Initial Date FDA Received: 10/27/2014
• Supplement Dates Manufacturer Received: 10/21/2019
• Supplement Dates FDA Received: 11/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2013
• 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 Age: 17 YR