MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 104; GENERATOR

Model Number 104

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Congestive Heart Failure (1783); Dyspnea (1816); Tachycardia (2095); Ulcer (2274); Complaint, Ill-Defined (2331)

Event Date 01/01/2013

Event Type  Injury  

Event Description

Follow-up with the physician revealed that the device was disabled on (b)(6) 2015.The physician stated it was unknown whether it will be re-enabled at a future date.The patient reports that dyspnea decreased after disabling.The patient stated they feel better overall after disabling.The device was turned off to prevent serious injury related to the report of tachycardia.

Event Description

It was reported that the vns patient was experiencing the following events which the physician believed were related to vns: congestive heart failure, stomach ulcers, tachycardia not associated with stimulation, dyspnea not associated with stimulation, and voice alteration.The physician elected not to disable the patient¿s device due to its effectiveness in reducing the patient¿s suicide attempts and depressive episodes.The physician noted that vns is not the source of these issues but believed that may be contributing to the patient¿s events.Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Pt ag: age at time of event: the initial report inadvertently reported the age incorrectly.Date of event: the initial report inadvertently reported the event date incorrectly.The physician reported the patient developed the congestive heart failure over the past few years.

• Brand Name: PULSE GEN MODEL 104
• 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: 4623006
• MDR Text Key: 5646511
• Report Number: 1644487-2015-04196
• Device Sequence Number: 1
• Product Code: MUZ
• 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,Followup
• Report Date: 02/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2013
• Device Model Number: 104
• Device Lot Number: 201757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/27/2015
• Initial Date FDA Received: 03/23/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/20/2015; 04/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2011
• 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): Other; Required Intervention
• Patient Age: 47 YR