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

Device Problem Programming Issue (3014)

Patient Problem Sleep Dysfunction (2517)

Event Date 01/01/2014

Event Type  Injury  

Event Description

An article titled ¿an electrical cause of stridor: pediatric vagal nerve stimulators¿ was received which reported that the (b)(6) year old child patient initial presented with difficulty sleeping, apneic episodes, frequent awakenings, and noisy breathing during the day.These symptoms began after implantation of a vns device.Polysomnography (psg) demonstrated mild osa with an apnea-hypopnea index (ahi) of 3 and the patient subsequently underwent tonsillectomy, adenoidectomy and inferior turbinoplasty.At his (b)(6) month post-operative appointment, the patient¿s symptoms had improved, but apneic episodes continued during the day and at night.Postoperative psg demonstrated persistent osa with an ahi of 1.5.On physical examination, the patient demonstrated episodic stridor and increased work of breathing.The patient¿s nasopharyngoscopic examination was notable for intermittent decreased motion of his left tvc.Airway evaluation in the operating room, in conjunction with a pediatric neurologist, revealed adduction of the left tvc and contraction of the left supraglottis during stimulation on-times.The patient¿s device output current was decreased to 1.75 ma and device on-time was changed to 3 min.The patient¿s tvc and supraglottic contractions ceased, his stridor and osa resolved, and he continued to have excellent seizure control 3 years after these adjustments.The other patient involved in this article was reported in manufacturer report # 1644487-2015-03618.Attempts for additional relevant information have been unsuccessful to date.

• Brand Name: PULSE GEN MODEL UNK
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS; 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: 4425832
• MDR Text Key: 5372945
• Report Number: 1644487-2015-03619
• 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: Literature,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2015
• 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: 12/18/2014
• 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): Other; Required Intervention
• Patient Age: 6 YR