MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 104; GENERATOR

Model Number 104

Device Problems No Display/Image (1183); Premature End-of-Life Indicator (1480); Low impedance (2285); Low Battery (2584); Improper Device Output (2953)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/17/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Clinic notes were received for the patient indicating replacement was planned.The patient has been implanted for less than a year.Per the referral request, the reason for the surgery was lead impedance change.Per the clinic notes, on office visit dated (b)(6) 2016, the vns battery was found to be at ifi=yes.The clinic notes stated there was low impedance, however, the impedance value was 4793 ohms, which is within normal limits.It was also noted that the patients settings were at 2.0ma but the device was only delivering 1.75ma of therapy.It is believed that when the physician stated there was low impedance, he was actually referring to the low output current.The device programmed to 2.0ma was likely unable to deliver the intended current.After applying ohms law with the tolerance of the lead impedance measurement, it is likely the device would not be able to deliver that programmed output current with the given lead impedance and =/- 25% tolerance for lead impedance.No additional relevant information has been received to date.No surgery has occurred to date.

Event Description

Patient underwent surgery.During the surgery, the surgeon repaired the patient's lead.No devices were reported to have been explanted.No additional relevant information has been received to date.

Event Description

A battery life calculation was performed with the last known device settings from the clinic notes.The results revealed 2.2 years of battery life remaining.

Event Description

The patient's father reported that his son has had problems with his current vns generator since its implant in 2016, including the complaint that magnet mode stimulation did not seem to have its expected impact on the patient.The father also suggested there may be a problem with the generator battery longevity.Per the patient's father, the physician did not identify issues with the impedance of the vns system at a recent clinic visit; however, the battery life remaining indicator appeared to switch between 25% and 50% within the same clinic visit.A company representative reported that the physician was concerned about the battery status of the generator because of the changing battery status indicator during the most recent clinic visit.The physician also believed that the battery had depleted faster than expected based on the date of implant and the patient's current vns settings.Clinic notes from the patient's two most recent visits indicated that the battery life indicator displayed 25% life remaining upon interrogation at the beginning of the clinic visit, and 50% life remaining at the end of the visit.The intensified follow-up indicator = yes was not observed at either clinic visit.Diagnostics for the generator were within the normal limits.The patient was referred for surgery.No additional relevant information has been received to date.No surgical intervention has occurred to date.

Event Description

Programming history was reviewed for the patient's device.System diagnostics tests indicated that impedance was within the normal limits throughout the available history; however, several diagnostic tests showed instances of elevated impedance, resulting in the device delivering a lower output current than programmed due to the increased impedance.This is expected behavior of the generator.The settings were adjusted to a deliverable output current several times over the available programming history in response.A further review of the available programming history did not indicate that the battery was depleting faster than expected.The device was never observed to have reached the intensified follow-up indicator battery status.No additional relevant information has been received to date.No surgical intervention has occurred to date.

• Brand Name: PULSE GEN MODEL 104
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6112562
• MDR Text Key: 60862415
• Report Number: 1644487-2016-02668
• 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: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/15/2017
• Device Model Number: 104
• Device Lot Number: 203398
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2015
• 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 Age: 24 YR