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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Syncope (1610); Arrhythmia (1721); Paralysis (1997)

Event Date 10/01/2017

Event Type  malfunction  

Manufacturer Narrative

Balasubramanian k, harikumar k, nagaraj n, sandipan p.2017.Vagus nerve stimulation modulates complexity of heart rate variability differently during sleep and wakefulness.Annals of indian academy of neurology.20:403-407.(b)(4).

Event Description

It was reported via article received by the manufacturer that the patient experience vocal cord paralysis due to the vns surgery.It was also stated that the patient experienced recurrent episodes of syncope and dizziness as well as an aberrant activation of the cardiac parasympathetic system contributing to bradycardia and subclinical seizures.No additional relevant information has been received 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: 7155717
• MDR Text Key: 96113898
• Report Number: 1644487-2017-05095
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 12/06/2017
• 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
• Patient Age: 37 YR