• 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 101

  • 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 101 Back to Search Results
Model Number 101
Event Date 01/01/2004
Event Type  Injury  
Event Description

Reporter indicated that the pt began having grand mal seizures approximately 5 years ago, which he did not have before vns was implanted. It was also noted that the pt has had an increase in his seizure activity. Info suggests that a number of medication changes have occurred to try to help control the pt's seizures more effectively. Info received suggests that the pt was receiving vns therapy for approximately 3 years prior to the onset of the grand mal seizures, and no timeline is known for the onset of the increased seizure activity. All attempts for further info have been unsuccessful, thus the relationship between the reported events and vns therapy cannot be determined.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 101
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd. ste. 600
houston , TX 77058
2812287200
MDR Report Key1449915
Report Number1644487-2009-01811
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/29/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/25/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/28/2003
Device MODEL Number101
Device LOT Number4309
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/29/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/01/2001
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: 08/25/2009 Patient Sequence Number: 1
-
-