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 Chest Pain (1776); Ecchymosis (1818); Hematoma (1884)

Event Date 10/14/2021

Event Type  Injury  

Manufacturer Narrative

Device return is not needed as the cause of the event is known and return would not add value to the investigation.

Event Description

It was reported that patient was rushed to the hospital after being hit in the chest over the vns device with a football.He was evaluated for swelling and given antibiotics.There is no redness and no temperature but swelling is the same and pain has increased.An update was provided that antibiotics were started and he has hematoma from contact injury.Doesn¿t want to drain and give a pathway for infection.Patient's mother provided more history that bully hit him in school on the device.Was seen in morning an device was working fine.Was then hit over device in afternoon football practice.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: 12796383
• MDR Text Key: 280687659
• Report Number: 1644487-2021-01561
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/11/2021

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: 05/06/2023
• Device Model Number: 1000
• Device Lot Number: 205568
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/20/2021
• 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; Other
• Patient Age: 9 YR
• Patient Sex: Male