MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

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

Patient Problems Arrhythmia (1721); Dyspnea (1816); Pain (1994)

Event Date 11/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by a patient that approximately 2 months prior, he woke up with shoulder pain and was having difficulty breathing.The patient went to the hospital and remained there for 5 days, and the physicians told him that his heart rate had decreased to 30 beats per minute.He said that the physicians determined that the shoulder pain and difficulty breathing were caused by the bradycardia and lower oxygen levels, but the physicians were unsure if the patient's bradycardia was caused by the vns.No further relevant information has been received to date.

Event Description

The patient's spouse reported that every time the patient's vns settings are adjusted, he goes through a period of a week where every time stimulation occurs (every minute) his heart rate drops to 30 bpm.It was reported that everything was cardiologically within normal limits.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 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: 6300371
• MDR Text Key: 66473580
• Report Number: 1644487-2017-03130
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 03/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2012
• Device Model Number: 103
• Device Lot Number: 2723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2010
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 43 YR