MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 105; GENERATOR

Model Number 105

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

Patient Problems Chest Pain (1776); Dysphagia/ Odynophagia (1815); Dyspnea (1816); Pain (1994); Seizures (2063); Discharge (2225)

Event Date 07/20/2015

Event Type  Injury  

Manufacturer Narrative

Event Description

It was reported the patient is experiencing severe pain and dyspnea.The pain was noted to be located at the neck and the generator site.The patient's caregiver is interested in having the device explanted.Settings were lowered, but symptoms did not resolve.The device was programmed off to assess for efficacy.Attempts for additional relevant information have been unsuccessful to date.No known surgical interventions have been completed to date.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient underwent vns explantation surgery as, since the previous generator's replacement, the patient had experienced dysphagia, voice complication, drooling, discomfort at vns site, weight lost, pain, and was still having seizures.It was stated that patient would keep hitting at his chest and was obsessed with generator site and wanted it out.Approximately three and half years prior, the vns output current was programmed off with only the magnet mode enabled for rescue.The explanted products have not been received by the manufacturer to date.

Event Description

It was reported by the patient's mother that the patient was experiencing an increase in seizures while waiting to have the vns explanted.It was stated that the patient was a twiddler.It was last reported to the manufacturer that the device had been disabled and it is unknown whether the device had remained programmed off, which would result in a loss of vns therapy.

Event Description

During attempts for product return, it was revealed that the explanted products appeared to have been discarded by the facility.

Event Description

It was reported via clinic notes received that the patient was referred for explant surgery due to the pain that continued despite vns disablement and a reported lack of magnet usage as well as a reported lack of efficacy.It was stated that the magnet mode had previously been left enabled.

• Brand Name: PULSE GEN MODEL 105
• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5143696
• MDR Text Key: 28044935
• Report Number: 1644487-2015-06087
• Device Sequence Number: 1
• Product Code: LYJ
• 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: Physician
• Type of Report: Followup,Followup,Followup,Followup
• Report Date: 03/25/2019

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: 05/31/2015
• Device Model Number: 105
• Device Lot Number: 202553
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/11/2015
• Supplement Dates Manufacturer Received: 10/24/2018; 01/15/2019; 02/15/2019; 03/22/2019
• Supplement Dates FDA Received: 11/14/2018; 02/07/2019; 03/12/2019; 03/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2013
• 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; Required Intervention
• Patient Age: 16 YR