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 Anxiety (2328); Sleep Dysfunction (2517); Cognitive Changes (2551)

Event Date 05/03/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient was initially implanted with vns.The patient is autistic and since his third post-op day, the patient has had a drastic increase in aggressive behavior, sleeping difficulties, and agitation.Autostim threshold was altered and all settings were turned off except for magnet mode.The patient's behavior was still bad and is assumed to be due to the feeling of the device itself as opposed to the stimulation.Parents of the patient want the device explanted.Information was received indicating that the aggressive behavior, sleep disturbances and agitation are believed to be due to discomfort of the device.The patient was referred to have device explanted for patient comfort and to preclude serious injury.It was stated that it is to preclude serious injury due to self-injury behaviors.No surgical intervention has been reported to date.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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8695881
• MDR Text Key: 147895337
• Report Number: 1644487-2019-01122
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/16/2021
• Device Model Number: 1000
• Device Lot Number: 6196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 05/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2019
• 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: 17 YR