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

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problems Dysphagia/ Odynophagia (1815); Fever (1858); Pneumonia (2011)

Event Date 04/13/2014

Event Type  Injury  

Event Description

Additional information was received that confirmed that the patient did have a history of swallowing issues with aspiration and the issues with the drooling and aspiration pneumonia are unrelated to vns.

Manufacturer Narrative

Event Description

It was reported that the patient has experienced drooling since changes in device settings from 30 seconds on and 5 minutes off to rapid cycling (7 seconds on; 0.3 minutes off).The patient's father reported that the patient has fluid in her lung with fever of 105 degrees.The patient's father reported that the patient has probable aspiration pneumonia and he is driving the patient to the hospital.It was reported that the patient would be seen by the physician to change device settings back to previous settings.The patient has a pre-vns history of swallowing issues with aspiration.Attempts to obtain additional relevant information have been unsuccessful to date.

• Brand Name: PULSE GEN MODEL UNK
• 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: 3892553
• MDR Text Key: 5120590
• Report Number: 1644487-2014-01580
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 7 YR