• 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 302

  • 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 302 Back to Search Results
Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/29/2017
Event Type  Injury  
Event Description

It was reported that the patient's vns was bothering her in her neck and shoulder. The physician referred the patient for generator replacement surgery due to the pain and for better seizure control. It was later reported that the patient's vns generator was completely depleted, which indicated that the issue that the patient was experiencing in the neck and shoulder were most likely not related to stimulation. Attempts for further information were unsuccessful to date. No known surgical intervention has occurred to date.

 
Event Description

The patient's mother reported that the patient also felt an electrical shock throughout her body when the device went off, and the physician told her that this was normal. The patient also reportedly experienced lead protrusion and discomfort. No surgical intervention has occurred to date.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLEAD MODEL 302
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 Key6682630
Report Number1644487-2017-04079
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 08/08/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/30/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2008
Device MODEL Number302-20
Device LOT Number1022
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/14/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/05/2005
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: 06/30/2017 Patient Sequence Number: 1
-
-