MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 103; GENERATOR

Model Number 103

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

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

Event Date 01/08/2021

Event Type  Injury  

Event Description

It was reported that after a patient's duty cycle was changed the patient experienced low blood pressure which caused the patient to lose consciousness.The patient was hospitalized and the vns was disabled with the magnet.The patient's blood pressure then returned to normal.Information was received that the believed relationship between the high blood pressure and the vns is that it is related to stimulation.It was reported that the patient's blood pressure was very low, and the patient had decreases in consciousness due to the low blood pressure.The cardiological and neurological examinations could not explain these complaints.After hospitalization, they ensured that the blood volume was restored via iv.The vns was switched off by placing the magnet and since then the blood pressure has returned to normal.The vns is now turned off.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 11283242
• MDR Text Key: 230441978
• Report Number: 1644487-2021-00162
• Device Sequence Number: 1
• Product Code: MUZ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/04/2021

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: 02/06/2015
• Device Model Number: 103
• Device Lot Number: 202415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 02/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• 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; Other; Required Intervention