• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CYBERONICS - HOUSTON PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/12/2012
Event Type  Injury  
Event Description

It was reported that the patient was having issues with the vns. It was stated that the patient was experiencing asthma, tightness, and a tight throat while attempting to eat during stimulation on times. The vns was previously disabled due to these events, but then was programmed back on. Follow up with the physician's office revealed that the patient stated that she previously had asthma when she was younger and was diagnosed with mild seasonal asthma, but that it had increased. It was unclear if the increase coincided with the implantation of the vns. It was reported that the patient was on oxygen and had a pre-existing pulmonary dysfunction and that the patient's test results were very abnormal. It was stated that the patient may have chronic obstructive pulmonary disease, or copd. The patient stated that she had difficulty swallowing with vns stimulation due to the tightness, but the patient also experienced difficulty breathing through her nose previously, which was why the patient was on oxygen. The patient stated that she was on oxygen immediately following the vns implantation surgery due the pulse ox readings being so bad. The patient was forced to discontinue oxygen use previously due to insurance issues, but upon recently getting back on oxygen, stated that she felt better. The patient had previously been on steroid inhalers and then an asthma disk. The patient reported that she sometimes anticipated the stimulation, would tense up, and then have difficulty swallowing or drinking. However, it was stated that when she was sitting, the patient was fine and did not even perceive stimulation. The patient felt that she anticipated the previous vns on time and that it was too long. The patient was referred for a swallowing study and would also have a ct scan. The patient's stimulation on and off times were reduced to shorter periods and the output currents were increased. No additional relevant information has been received to date.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
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 Key7299811
Report Number1644487-2018-00293
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 02/27/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/27/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/19/2014
Device MODEL Number103
Device LOT Number202174
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/07/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/11/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/27/2018 Patient Sequence Number: 1
-
-