• 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 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, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 01/03/2014
Event Type  Injury  
Event Description

Additional information was received stating that the vns patient has not been re-implanted to date.

 
Event Description

It was reported that the generator and lead were explanted and that the patient will be reimplanted in about two weeks. It was reported that there was some concern about the patient developing an infection. The patient was placed on antibiotics.

 
Event Description

The physician reported that there is a "5 mm open area that appears to be a wire" on the patient's neck. The patient's brother was observing the patient and stated that he believed the patient rubbed the area and created the opening. The patient had a consult for surgery on (b)(6) 2014. System diagnostics were normal. The surgeon attributes the exposure to patient manipulation. No medication or treatment changes preceded the issue. The family was not aware when the issue started. The patient has been referred for surgery. Surgery is likely, but has not occurred to date.

 
Event Description

The patient underwent generator and lead reimplant.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLEAD MODEL 304
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
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 Key3595152
Report Number1644487-2014-00312
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 01/03/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/28/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2016
Device MODEL Number304-20
Device LOT Number3348
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/11/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/08/2012
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: 01/28/2014 Patient Sequence Number: 1
-
-