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 Problem Local Reaction (2035)

Event Date 03/18/2021

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary as the local reaction is not related to the functionality or delivery of therapy of the device.

Event Description

It was reported the patient had itching and rashy red bumps on skin around the generator implant site.The rash started couple of days after surgery and is spreading to the patient's back and down her arm.The surgeon gave her hydrocortisone cream.The patient reported increased itching of the whole area.Information was received that the surgeon thought that the patient may be allergic to dermabond - adhesive used in vns surgery to hold skin together.They sent her to the dermatologist to help out to figure out what the cause could be.It was noted that initially the patient's skin was just red around the incision site a week after.Then the patient came back with a raised rash on neck, shoulder, chest, face.The patient had gone to urgent care to get steroid cream, was not admitted.The nurse also stated they were able to take off all of the dermabond in the visit with the patient and they have not heard back from the dermatologist.No additional 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 11753449
• MDR Text Key: 248214224
• Report Number: 1644487-2021-00584
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2022
• Device Model Number: 1000
• Device Lot Number: 6802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/06/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/21/2021
• 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): Required Intervention
• Patient Age: 40 YR