• 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 09/07/2010
Event Type  Injury  
Event Description

It was reported that a vns pt experienced a new type of seizure as the pt began to experience brief tonic-clonic seizures that lasted 10-20 seconds and were increasing in frequency. The pt had recently undergone vns placement and was not programmed on after surgery. The pt was programmed on at a follow-up appointment with the treating neurologist. The neurologist believed the increase in change was possibly due to the anesthesia or trauma/stress but could not confirm. Additional info was received through a fax with clinic notes which stated: "there has been an increase of seizure frequency, especially brief episodes. Given his increased seizure frequency, i am recommending checking drug levels today. Vns was also started at. 25 ma ever 180 min. He appeared to tolerate this procedure well. ".

 
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 Key1872832
Report Number1644487-2010-02305
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/15/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/14/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2012
Device MODEL Number103
Device LOT Number2740
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received09/15/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2010
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: 10/14/2010 Patient Sequence Number: 1
-
-