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

Event Date 01/30/2019

Event Type  Injury  

Manufacturer Narrative

Event Description

It was reported that the patient was in the hospital with asthma. The clinician wondered whether the vns could contribute to the asthma. No further relevant 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: 8364063
• Report Number: 1644487-2019-00350
• Device Sequence Number: 1
• Product Code: LYJ
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/20/2019

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 02/22/2019
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: LAY USER/PATIENT
• Device MODEL Number: 106
• Device LOT Number: 204429
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: Other
• Date Manufacturer Received: 02/27/2019
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 03/28/2018
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 02/22/2019 Patient Sequence Number: 1