• 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 302-30
Event Date 11/01/2006
Event Type  Malfunction  
Event Description

It was reported that system diagnostic testing for a vns pt resulted in high impedance readings. The high impedance issue was discovered after the pt had been playing tennis. The pt also reported feeling neck pain on the left side with device stimulation after a tennis game. X-rays were taken and sent to mfr for review, and assessment of the x-rays revealed a gross lead fracture near the generator and another possible fracture between the negative and positive electrode. The pt's treating physician indicated that the observed lead discontinuities were likely related to stresses from the pt playing tennis. The pt may in the future be scheduled for revision surgery.

 
Event Description

On (b)(6) 2014, the patient reported that he could not receive an mri due to the broken lead in his neck. He stated that the break occurred sometime in 2007 or 2008 and he could not remember the details of the event. Although lead removal surgery is likely, it has not occurred to date.

 
Event Description

It was later reported that the patient is considering having the vns explanted due to the lead fracture as he is no longer using it.

 
Manufacturer Narrative

Mfr reviewed x-rays of implanted device. Review of x-rays by mfr revealed a gross lead discontinuity. Device malfunction suspected, but did not cause or contribute to a death or serious injury. See scanned page.

 
Manufacturer Narrative

Supplemental manufacturer report #02 inadvertently did not include the date the supplemental information was received ((b)(4) 2014).

 
Event Description

The patient¿s generator was disabled on (b)(6) 2006 in response to the lead fracture event.

 
Manufacturer Narrative

The initial report inadvertently did not state that the patient¿s generator was disabled as a result of the lead fracture event.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLEAD MODEL 302
Manufacturer (Section D)
CYBERONICS, INC.
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 Key1119852
Report Number1644487-2008-01891
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/01/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/13/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2009
Device MODEL Number302-30
Device LOT Number200310
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received02/05/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-