• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • 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

Model Number 102
Event Date 02/01/2013
Event Type  Injury  
Event Description

It was reported that the patient's device has been turned off for a few years with perceived lack of efficacy (however, review of the manufacturer's programming history shows the device was programmed on in (b)(6) 2011, the last known date of history programmed by the nurse practitioner). The family requested to have it turned back on as vns therapy may help the patient. Upon turning back on, magnet stimulation caused the patient pain and he became cyanotic. Therefore, the magnet output current was decreased, and the device is currently on with no issue. The physician wants to replace the device due to the length of implant. Follow-up with the nurse practitioner revealed that the cyanosis is believed to be related to the battery nearing end of service although the eri flag is no. The magnet stimulation was only 0. 25 ma above the normal output current, and magnet use caused a violent cough and cyanotic episode. This led the nurse to believe the battery may be dying. The patient does not have a medical history of cyanosis, and there were reportedly no causal or contributory programming or medication changes precede the onset of the events. The patient's mother reported the device had been off for about 3-5 years, but this is not substantiated by the history in the manufacturer's database. Stimulus is on every minute and a half. The nurse indicated that there is suspected potential erratic stimulation as the battery is clearly not completely off as the patient is receiving therapy via witnessed voice vibration and cough, which she noted is just the patient's reaction to stimulation. She is not sure if the patient's symptoms are related to the device being turned off for some time. Both normal and system diagnostics were all okay but the specific results and programming settings were not provided. The patient is referred for generator replacement due to clinical end of service. Although surgery is likely, it has not occurred to date.

Event Description

The implant card was received which reported that the patient had prophylactic generator replacement surgery on (b)(6) 2013. It was reported that the explanted device has been discarded since the device has not been sent back to the manufacturer to date.

Manufacturer Narrative

The initial report inadvertently reported the age incorrectly due to the date of event being reported inadvertently incorrectly. (b)(4).

Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceGENERATOR
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key2993702
Report Number1644487-2013-00639
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/08/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/07/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2005
Device MODEL Number102
Device LOT Number010324
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/18/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/04/2004
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial