• 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. PULSE GEN MODEL 103

  • 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. PULSE GEN MODEL 103 Back to Search Results
Model Number 103
Event Date 08/01/2010
Event Type  Injury  
Event Description

It was reported that the vns patient experienced a sudden onset of painful stimulation in the neck with magnet mode stimulation. Follow up with the treating physician revealed that there were no causal or contributory programming changes or trauma that preceded the onset of the event. Recent diagnostic testing done on the device has revealed normal device function. X-rays were taken and sent to manufacturer for review. Review of x-rays revealed no anomalies that could be contributing to the reported event. The physician opted to decrease the device settings when the event initially began, which did appear to provide some relief initially. However, the patient had contacted the physician's office several days later, experiencing severe dysphagia, and the physician programmed the normal mode output current off at that time. The patient requested that the magnet mode stimulation remain programmed on, as she uses the stimulation for anxiety. Good faith attempts to obtain additional information are currently underway.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 103
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1851127
Report Number1644487-2010-02207
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/31/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/30/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2010
Device MODEL Number103
Device LOT Number200882
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/31/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2008
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: 09/30/2010 Patient Sequence Number: 1
-
-