MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Insufficient Information (3190)

Patient Problems Apnea (1720); Sleep Dysfunction (2517)

Event Date 01/01/2013

Event Type  Injury  

Event Description

Clinic notes dated (b)(6) 2013 note that the patient has sleep apnea.The relationship of the sleep apnea to vns is unknown.Attempts to obtain additional information have been unsuccessful to date.

Event Description

The psychiatrist later reported on (b)(6) 2014 that the sleep apnea was not mentioned until (b)(6) 2013.He had been referred for sleep studies by his internist on (b)(6) 2012 but results were not available to the psychiatrist.His last vns treatment took place on (b)(6) 2013.Neither patient nor psychiatrist established a relationship between vns and his sleep apnea.It was noted that the patient had been taking an unusually high dose of lunesta ~6mg nightly, but always reported resting well.The physician reported that it is possible that after he started vns treatment, he would wake up earlier in the morning, sleeping fewer hours, but waking up refreshed.The physician said the patient never reported side effects, and no untoward events were observed, even when changing his parameters.The only medication change in his regimen took place on (b)(6) 2012 from zyprexa 30mg to abilify 15mg, daily.

• Brand Name: PULSE GEN MODEL 102
• 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: 3547101
• MDR Text Key: 4102187
• Report Number: 1644487-2014-00010
• 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
• Report Date: 12/05/2013

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: 11/30/2007
• Device Model Number: 102
• Device Lot Number: 014818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/23/2014
• Initial Date FDA Received: 01/02/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2006
• 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
• Patient Age: 56 YR