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); Pain (1994)

Event Date 05/07/2019

Event Type  Injury  

Event Description

It was reported that the patient's vns was "misfiring" and had fired 36 times in one day.The er physician indicated that the vns kept going off every minute per the patient and would not stop.Magnet disablement was recommended, but the patient and facility requested a company representative program the vns off.A second call was received from the facility.Magnet disablement resolved the issue, but it was still requested to have the vns programmed off.It was believed by the medical professional that the patient experienced painful stimulation since they requested the vns programmed off.The patient was discharged from the facility.Information was later received indicating that the ¿misfiring¿ meant the patient experienced a shocking sensation and that the medical professionals did not wish to disable the vns as they did not want the patient to have seizures.The diagnostics from the latest clinic visit after the admission were reported as within normal limits.The patient was referred for a vns lead replacement surgery due to the painful stimulation.No relevant surgery is known to have occurred to date.No additional relevant information has been received to date.

Event Description

The patient underwent a full vns replacement surgery.The explanted products were received by the manufacturer and are pending product analysis.Follow up with the physician's office revealed that the reported misfiring was painful stimulation at the top of the generator, which resolved with lowered settings and disablement, but the patient experienced seizures when this occurred.

Event Description

It was reported by the patient that the vns lead was checked multiple times before surgery, which was a reference to diagnostic tests on the vns, and that the physicians did not find anything wrong with the lead until it was explanted.It was stated by the patient that the lead was found to have damage.The patient stated that he believed he had a lead issues that were not picked up by the diagnostics previously.Follow up with the company representative that attended the replacement surgery revealed that neither he or the surgeon had observed any obvious damage of the lead at the explant surgery.

Event Description

Generator product analysis was completed.The allegations of altered perception of stimulation and painful stimulation could not be evaluated in the product analysis, or pa, lab.However, the proper functionality of the generator in its ability to deliver appropriate programmed output currents was successfully verified in the pa lab.The septum was not cored, which eliminates the possibility of potential unintended electrical current paths through body fluids.The generator was placed in a simulated body temperature environment and monitored for more than 24 hours.No signs of variation in the output signal were observed and the diagnostics were as expected.The generator performed according to functional specifications.There were no performance or other adverse conditions found with the generator.Lead product analysis was completed.The allegations of altered perception of stimulation and painful stimulation were beyond the scope of activities performed in the product analysis, or pa, lab.The portion of the lead containing the electrodes was not returned for analysis and, therefore, a complete evaluation could not be made as to the entire lead.The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No discontinuities were identified in the return lead portion.There was no evidence to suggest any anomalies with the returned portion of the lead.

• 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: 8654203
• MDR Text Key: 146507384
• Report Number: 1644487-2019-01044
• 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,consum
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/02/2021
• Device Model Number: 1000
• Device Lot Number: 204771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 33 YR