MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 1000; GENERATOR

Model Number 1000

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

Patient Problems Inflammation (1932); Muscle Spasm(s) (1966); Pain (1994)

Event Date 06/28/2020

Event Type  Injury  

Event Description

The patient complained of the vns vibrating for 10 minutes one day and then again for an unknown amount of time.The patient stated it was painful and hot.The physician turned off the device, she did not see any redness but when she lightly touched the area the patient stated that it was painful.The patient was sent to the emergency department to get a chest x-ray to rule out alternative complications.The nurse noted she has not confirmed if the patient did go get the x-ray.Per the nurse, the patient felt the warm and vibrating sensation at the generator site and the feeling did not radiate.Specifically, she did not feel it near the lead.It was noted that the sensation started and stopped, but the warm sensation did not cease at any point.It was noted that there was no redness or swelling at the incision site and no temperature difference between the skin over the battery vs the surrounding area.Regarding the cause of the vibration feeling, it was stated that the vns was turned off due to the lack of evidence of fault with the vns.The cause of the vns site feeling hot is unknown.It was noted that the intervention of device disablement was to avoid any injury and for patient comfort.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 1000
• 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: 10320811
• MDR Text Key: 200257795
• Report Number: 1644487-2020-00993
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• 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: Other
• Type of Report: Initial
• Report Date: 07/24/2020

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: 09/19/2019
• Device Model Number: 1000
• Device Lot Number: 204261
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2017
• 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: 27 YR