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

Model Number 102

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

Patient Problems Syncope (1610); Low Blood Pressure/ Hypotension (1914)

Event Date 12/09/2016

Event Type  Injury  

Event Description

It was reported that the patient had been having episodes of lost consciousness 1-2 times per week since having his vns duty cycle increased.The patient recently had his hypotension medicine adjusted at around the same time.The doctor planned to increase the off time to evaluate the vns's role in the episodes of syncope.Recent diagnostics confirmed device function.No further relevant information has been received to date.No known surgical intervention has occurred to date.

Event Description

The psychiatrist reported that the believed cause of the syncope was pre-existing orthostatic hypotension that may have been worsened by the vns.Prior to this, the patient had symptoms of dizziness for 10 years and the patient was being treated by a cardiologist for their hypotension symptoms.Per the patient's psychiatrist, it was unclear whether the patient's symptoms worsened when the off-time was changed.Cardiology believed the symptoms to be secondary to polypharmacy; however the psychiatrist noted that the patient's symptoms did appear to improve when the patient's vns off time was increased to 5 minutes.Reportedly, the patient's primary care physician, cardiologist and psychiatrist had been adjusting medications at the same time the vns was being adjusted.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• 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: 6324079
• MDR Text Key: 67182678
• Report Number: 1644487-2017-03176
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2017

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: 05/15/2017
• Device Model Number: 102
• Device Lot Number: 203427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/18/2017
• Initial Date FDA Received: 02/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2015
• 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: 55 YR