MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problems Tachycardia (2095); Convulsion, Clonic (2222); Confusion/ Disorientation (2553)

Event Date 03/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient had an episode of increased heartrate and discoloration of his arm.After that episode, he was in and out of the hospital at least 3 times.During the admissions, he began developing memory loss and confusion.Between admissions, the patient had a "bad seizure" and mom swiped the magnet because "he looked dead." he had fever, nausea/vomiting, and mom drove him to the hospital.In the er, he was still nonresponsive but per the mother they treated him like a psychiatric case.The mother, however, wanted the vns checked as she was unsure the vns was working and was concerned that there was something else beyond psychiatric issues.When the patient's device was turned off for an mri, it was determined that the patient's vns was set to correct settings and was functioning normally.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• 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: 11792551
• MDR Text Key: 250227768
• Report Number: 1644487-2021-00631
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: 05/07/2021

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: 01/10/2020
• Device Model Number: 106
• Device Lot Number: 204358
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 04/14/2021
• Initial Date FDA Received: 05/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2018
• 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
• Patient Age: 19 YR