MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problem Arrhythmia (1721)

Event Date 06/22/2017

Event Type  Injury  

Event Description

It was reported that following the initial vns implant surgery for the patient, the patient experienced a heart rate drops to 30 beats per minute.There were no reported issues during the implant procedure.The facility historically programs vns patients on to lower settings at implant and monitors the patient overnight.It was reported that patient has had some previous medical issues.Follow up with the company representative revealed that the patient was on a monitor at home, though the representative was unclear if that meant a oxygen or heart rate monitor.It was reported that the patient has had some baseline issues and has had his heart rate drop before.No additional relevant information has been received to date.

Event Description

It was reported that the physician's office stated that the bradycardia had not occurred since the initial report of bradycardia.The vns was found to be working with no problems.The patient's mother confirmed that the patient has experienced a heart rate drop before.It was believed that this may have been a result of the anesthesia.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6711028
• MDR Text Key: 79950907
• Report Number: 1644487-2017-04139
• 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: company representative,consum
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2018
• Device Model Number: 106
• Device Lot Number: 5115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2016
• 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: 12 YR