MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

Device Problems Device Operates Differently Than Expected (2913); Output Problem (3005)

Patient Problems Device Overstimulation of Tissue (1991); Tachycardia (2095); Anxiety (2328)

Event Date 05/08/2015

Event Type  Injury  

Event Description

It was reported that the patient experienced an increase in heart rate associated with vns stimulation.The physician elected to turn down the output current from 1.5ma to 1.25ma to see if this would result in a decrease in heart rate.It was also noted by the patient that the stimulation on times made the patient feel anxious.The physician thought this could be related to the heart rate increase.Good faith attempts for additional, relevant information have been unsuccessful to date.

Manufacturer Narrative

Manufacturer Narrative

Suspect device udi, corrected data: the initial report inadvertently did not report this information.(b)(4).

• Brand Name: PULSE GEN MODEL 105
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058 770
• 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: 4789594
• MDR Text Key: 5803888
• Report Number: 1644487-2015-04768
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/12/2016
• Device Model Number: 105
• Device Lot Number: 203200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2014
• 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: 26 YR