MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

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

Patient Problems Muscle Spasm(s) (1966); Undesired Nerve Stimulation (1980); Pain (1994)

Event Date 02/20/2018

Event Type  Injury  

Event Description

It was reported that the patient went to the emergency room due to pain shooting up her neck and back of her head that had been occurring for a few hours.The patient also had spasms and twitching on the left side of her body.The physician wanted to disable the device, so instructions on how to use the magnet to disable it were given.The patient was then admitted to the icu and intubated due to unknown reasons, and it was reported that most of the patient's seizures were pseudo-seizures.The physician stated that the patient was reporting that her vns was misfiring, but he did not seem to believe the patient based on her report of false seizures.Because the patient had no insurance or following neurologist, the physician requested that the device be programmed off until it could be properly managed.No further relevant information has been received to date.

Event Description

It was reported that the patient was found at a bus stop in status, so she was hospitalized.The patient's device was communicated with, and everything was within normal limits.The physician did not believe the status episode was related to vns as the eeg showed no true seizure activity.The patient's device was functioning as intended.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• 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: 7343586
• MDR Text Key: 102569504
• Report Number: 1644487-2018-00410
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2018

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/11/2016
• Device Model Number: 103
• Device Lot Number: 203094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/20/2018
• Initial Date FDA Received: 03/15/2018
• Supplement Dates Manufacturer Received: 04/03/2018
• Supplement Dates FDA Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2014
• 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
• Patient Age: 35 YR