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 Vomiting (2144); Weight Changes (2607)

Event Date 09/01/2016

Event Type  Injury  

Event Description

The physician reported that they had to program the vns off due to the patient experiencing vomiting and weight loss as a side effect of the vns.The physician also notes that the patient's vomiting has resolved and that the patient has also gained weight.Further follow up with the physician confirmed that both vomiting and weight loss were thought to be caused by vns stimulation.The physician notes that this patient had an extensive work up including assessment from the physician's mental health and gi colleagues who could find no organic cause for these symptoms.The physician also notes that there has been no documented changes in medication or other treatments.The physician mentioned that device disablement was both for patient comfort and to avoid serious injury.The physician notes that by the time the vns was turned off the patient's weight loss was 9 kg and they were experiencing daily vomiting.The physician notes that the patient's vomiting has resolved since the device was disabled and that the patient has also gained weight.No other relevant information has been received to date.

Manufacturer Narrative

Relevant tests/laboratory data, corrected data: initial mdr report inadvertently listed wrong date for settings and device disablement.

• 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: 8331367
• MDR Text Key: 135880130
• Report Number: 1644487-2019-00245
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/05/2015
• Device Model Number: 102
• Device Lot Number: 202570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 02/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2013
• 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: 15 YR