MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 103; GENERATOR

Model Number 103

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

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994); Seizures (2063)

Event Date 12/01/2018

Event Type  Injury  

Event Description

The patient reported that they have experienced an increase in seizures, as well as difficulty swallowing due to the vns.The patient mentioned that they fell in (b)(6) 2018, and that after this fall it felt like the device was "chocking and hurting their throat." the patient stated that the settings were lowered after this fall, but that this had resulted in an increase in seizures.The patient mentioned that they went back to their physician for further vns adjustment, which the details were not provided.The patient reports that they are still having seizures and difficulty swallowing at this point in time.The patient's following physician reported that this patient has not kept follow up appointments; and therefore, the physician does not currently have an assessment on the patient's events.The physician noted that the patient was referred for neurological evaluation due to seizures, and that the patient was supposed to have vns tested, eeg & x-ray of the chest & neck to check leads; however, no results have been obtained to date.Regarding the patient's mention of vns setting adjustments, the physician clarified that in (b)(6) 2018 the patient requested that the off time be increased; however, the physician then adjusted off time to it's original settings 2 weeks later.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• 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: 8615383
• MDR Text Key: 145227794
• Report Number: 1644487-2019-00935
• 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: Other
• Type of Report: Initial
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/18/2013
• Device Model Number: 103
• Device Lot Number: 201943
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 04/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2011
• 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): Other
• Patient Age: 47 YR