MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problem Energy Output To Patient Tissue Incorrect (1209)

Patient Problems Fatigue (1849); Seizures (2063)

Event Date 03/19/2018

Event Type  malfunction  

Event Description

A company representative attended a clinic visit of a patient experiencing increased seizures and fatigue.The patient informed the nurse during the visit that he could no longer feel stimulation.Upon interrogation of the patient's device, a warning message was observed indicating that the output current was low and the 3ma output current could not be delivered as programmed.Impedance was within the normal limits during the clinic visit.A review of programming history revealed that the patient's generator had been programmed to high settings for nearly 1 year prior to the observance of the warning message.The nurse reported that the physician believed that the increased seizures and fatigue were related to the output current warning message.Clinic notes suggested that the warning message indicated that no current was detected.Due to the warning message, the physician reduced the programmed output current to 2ma.The patient then began to cough uncontrollably with stimulation, which he had not done since implant.The patient's settings were adjusted again.At a follow-up visit nearly one month later, the patient reported that he only had one short seizure since the initial visit.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• 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: 7431519
• MDR Text Key: 105526998
• Report Number: 1644487-2018-00582
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: Physician
• Type of Report: Initial
• Report Date: 04/13/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/06/2017
• Device Model Number: 106
• Device Lot Number: 4648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/19/2018
• Initial Date FDA Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 44 YR