• 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 LEAD MODEL 304

  • 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 LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problem Detachment of Device or device Component
Event Date 10/11/2018
Event Type  Malfunction  
Event Description

The patient was reported to have pain in their neck. The physician believes that there was curling of the lead and that the electrode is off of the nerve. The physician believed that the pain was due to the electrode coming off of the nerve. The pain was described as intense pain when laying on their left side or leaning their head to the left, and that it would resolve when the patient¿s head was turned to the right. Per an xray report received, there was some change in the lead configuration, but it was not specified what was different. No discontinuities were seen. X-rays were reviewed. The x-rays did not capture the generator and no assessment can be made on the position, lead wires, or feed through wires. In the portions of the lead visible, no gross lead fractures or other anomalies were observed. Based on the images provided, there is no obvious confirmation of the electrode coming off of the nerve. The device was interrogated and diagnostics were within normal limits. No additional or relevant information has been received to date.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLEAD MODEL 304
Type of DeviceLEAD
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 Key8133204
Report Number1644487-2018-02207
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 12/05/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/05/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number304-20
Device LOT Number203906
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Device Age23 mo
Event Location Other
Date Manufacturer Received11/16/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2016
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: 12/05/2018 Patient Sequence Number: 1
-
-