MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problems Fatigue (1849); Seizures (2063); Depression (2361); No Information (3190)

Event Date 11/01/2016

Event Type  Injury  

Event Description

It was reported that a patient's generator had "stopped working after a year" and that the patient's seizures were worsening.The neurologist stated that the only thing they could do was possibly change the battery.A battery life calculation was performed with the data available to the manufacturer and did not confirm likely depletion.No additional, relevant information was received to date.

Event Description

It was confirmed that the patient has been referred for vns replacement surgery due to a low generator battery.No known surgical intervention has occurred to date.

Event Description

It was reported that the patient's generator was replaced prophylactically.It was reported that the explanted generator was discarded; therefore, return of the suspect product is not expected to date.No further relevant information has been received to date.

Event Description

The patient reported to the sales representative that their battery is now at 2% battery life.Additionally, the patient reports seeing an increase in seizures every day.Additionally, the patient is waking up and feeling more fatigued and depressed, noting that vns had helped her depression immensely.No other relevant information has been received to date.No known surgical intervention has occurred to date.

• Brand Name: PULSE GEN MODEL 106
• 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: 8547828
• MDR Text Key: 143022047
• Report Number: 1644487-2019-00775
• Device Sequence Number: 1
• Product Code: LYJ
• 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,Followup,Followup
• Report Date: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/30/2017
• Device Model Number: 106
• Device Lot Number: 203465
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 01/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2015
• 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): Other
• Patient Age: 46 YR