• 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 04/01/2015
Event Type  Injury  
Event Description

It was reported that the patient had issues with a lead pulling sensation. The patient had a revision surgery to loosen up the lead for more range of motion for the patient and it was noted that the patient had fibrosis around the lead. No additional relevant information has been received to date.

 
Manufacturer Narrative

Describe event or problem - corrected information: the information included in describe event or problem on this report should have been included in the initial report as the surgery for the patient was due to the all of the adverse events reported for the patient. Relevant tests/laboratory data - corrected information: the settings and diagnostic data should have been included in the initial report. (b)(4).

 
Event Description

Information should have been included in the initial report that the patient also had painful stimulation and muscle spasms in the neck at the electrode site. The spasms in the patient's neck subsided when the vns magnet was placed over the generator to disable it. The patient's settings were adjusted multiple times and the normal and systems diagnostics were stated to be ok. The painful stimulation and muscle spasms were stated to not have resolved after the surgery to reposition the lead indicating that the surgery could have been to help alleviate those adverse events as well.

 
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 Key7155729
Report Number1644487-2017-05096
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 01/10/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/01/2017
Device MODEL Number302-20
Device LOT Number202560
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/10/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 12/29/2017 Patient Sequence Number: 1
-
-