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); Dyspnea (1816); Inflammation (1932); Pain (1994); Seroma (2069)

Event Date 11/02/2019

Event Type  Injury  

Event Description

It was reported by the patient that the patient's vns was stimulating every ten seconds or so and that the patient was experiencing difficulty breathing.The patient was advised to present to the hospital by her neurologist.It was stated that the facility "reset" the generator.The patient then reported that it was going off less frequently, but still more than normal.The patient reported the vns stimulating when she had only stood up.An x-ray and ct scan were performed while the patient was at the hospital and it was noted that the generator seemed to be floating in a pocket of fluid.The patient reported still being in a lot of pain and felt that the vns was stimulating too frequently still.No additional relevant information has been received to date.

Event Description

It was later reported by a company representative that the patient was evaluated to assess the frequency of vns stimulations and discomfort.The patient had complained of receiving too many autostimulations a day and that the device goes off frequently and, due to this, she experiences a bit of discomfort.The physician ordered an ekg to check for any abnormalities in the patient's heart rhythm and no anomalies were found.The patient then requested that the autostimulation threshold be lowered so that she receives more autostimulations despite the complaint that it was stimulating too frequently as she was paranoid that she would not feel stimulation.

Manufacturer Narrative

Describe event or problem, corrected data: initial report and follow-up report #1 inadvertently reported information regarding the temporary magnet disablement described as a "reset" which was unrelated to the reportable event of the seroma.Describe event or problem, corrected data: follow-up report #2 inadvertently reported information regarding frequency of autostimulations which was unrelated to the reportable event of the seroma.

Event Description

It was reported by the patient that she was scheduling a consult with the surgeon regarding surgery regarding adverse events related to vns stimulation.Follow up for the vns stimulation related events which were unrelated to the pocket of fluid reported in this mfr.Report revealed that the surgery would be for the patient's comfort.As it was previously reported that the patient was to be evaluated for comfort per the pocket of fluid, no additional reports will be reported for the pocket of fluid in which the generator was allegedly floating unless further relevant information is received after the completion of the surgery.

Event Description

Follow up with the physician's office and patient revealed that the patient was satisfied with her seizure control and the seizure activity was reported as below the pre-vns baseline.The reported "reset" was to place the magnet on top of the device and then remove the magnet.The er stated that the patient felt the stimulation due to the breakthrough seizure and was, therefore, more sensitive.The patient was referred to neurosurgery for evaluation of the reported pocket of fluid and discomfort.The patient reported that the generator site was sensitive and warm.There was no visual signs of infection, which was ruled out.Diagnostics were reported as within normal limits.It was stated that the patient was to be evaluated for comfort with no replacement planned.

• 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: 9364435
• MDR Text Key: 167651524
• Report Number: 1644487-2019-02279
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/18/2020

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: 03/21/2021
• Device Model Number: 1000
• Device Lot Number: 6190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 11/22/2019
• Supplement Dates Manufacturer Received: 11/27/2019; 01/06/2020; 01/24/2020
• Supplement Dates FDA Received: 12/19/2019; 01/24/2020; 02/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2019
• 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: 35 YR