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 Problem Seizures (2063)

Event Date 11/20/2018

Event Type  Injury  

Event Description

It was reported that the patient had an increase in seizures above their pre-vns baseline.No additional or relevant information has been received to date.

Event Description

Surgery is likely for the patient but has not occurred to date.No additional or relevant information has been received to date.

Event Description

The patient¿s generator was replaced due to prophylactic replacement.The explanting facility historically discards devices after surgery and the generator has not been received to livanova to date.No other information has been received 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: 8144024
• MDR Text Key: 129677152
• Report Number: 1644487-2018-02217
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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
• Report Date: 01/24/2019

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: 09/15/2018
• Device Model Number: 106
• Device Lot Number: 5044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: 20 MO
• Event Location: Other
• Initial Date Manufacturer Received: 11/20/2018
• Initial Date FDA Received: 12/07/2018
• Supplement Dates Manufacturer Received: 12/13/2018; 01/10/2019
• Supplement Dates FDA Received: 12/31/2018; 01/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2016
• 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: 33 YR