MAUDE Adverse Event Report: CYBERONICS INC PULSE GEN MODEL 103; GENERATOR

Model Number 103

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Nausea (1970); Pain (1994)

Event Date 09/28/2014

Event Type  Injury  

Event Description

It was reported that the vns patient was experiencing nausea and pain at her electrode site during stimulation on-times.The patient was later diagnosed with gastroparesis and it was determined that her stomach was not producing enough gastric juices to promote digestion.Endoscopy and colonoscopy were performed and adjustments to the device settings were planned.Attempts for additional relevant information will be made.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS INC; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS INC; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 4296768
• MDR Text Key: 5052850
• Report Number: 1644487-2014-03204
• 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: Consumer,Company Representative
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2014
• Device Model Number: 103
• Device Lot Number: 3495
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 11/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2012
• 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: 54 YR