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

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 303

  • 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, INC. LEAD MODEL 303 Back to Search Results
Model Number 303-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that the patient had a scope done by ent, and it was reported that the patient was experiencing intermittent vocal cord paralysis lasting for a 2 minute duration. The neurologist thinks it may be associated with the vns stimulation, so the plan was to adjust settings to see if this resolves the vocal cord paralysis. No additional relevant information has been received to date.

 
Manufacturer Narrative

(b)(4).

 
Event Description

The patient did not notice any vocal cord issue symptoms, but he had worsening respiratory status since vns implant. The patient was also hospitalized for pneumonia and swallow dysfunction during that time. The ent's scope evaluation confirmed that the left vocal cord was intermittently paralyzed. The most recent diagnostics were within normal limits. The physician was not certain of the results after the settings were adjusted, but the patient was not having an increase in seizures. The only other intervention being taken was slowly tapering the patient off of onfi. The patient was hospitalized in (b)(6) 2016 for pneumonia and hypoxia, and he was hospitalized in (b)(6) 2017 for aspiration. The physician believed that the worsened respiratory status and pneumonia was at least partially related to the vns, because the patient had multiple respiratory illnesses and aspiration after the vns was placed and because a bronchoscopy evaluation showed intermitted left vocal cord paralysis. No further relevant information has been received to date.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLEAD MODEL 303
Type of DeviceLEAD
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 Key6878375
Report Number1644487-2017-04479
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 02/12/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/20/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/09/2019
Device MODEL Number303-20
Device LOT Number4262
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/24/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/04/2015
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: 09/20/2017 Patient Sequence Number: 1
-
-