• 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 102

  • 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 102 Back to Search Results
Model Number 102
Event Date 08/31/2011
Event Type  Injury  
Event Description

Reporter indicated a vns patient was having increased seizures and drop attacks. The reporter was concerned the vns may be approaching end of life. The patient was recently seen by the treating neurologist and the generator was not at end of life per the neurologist. The reporter was encouraged to follow up with the treating neurologist for her concerns. A vns battery estimate performed yielded approximately 1. 5 years of battery life remaining. All attempts to the treating neurologist for further information have been unsuccessful to date.

 
Event Description

Manufacturer follow-up with the treating neurologist revealed the patient was having increased complex partial seizures, and it was not known if the increase was greater than pre-vns baseline seizure levels. The etiology of the seizure increase was unknown. No medication changes had occurred, and the vns was not at end of service. No vns programming events or other events precipitated the seizure increase. The vns settings were increased as an intervention. Since the vns settings were adjusted, there have been less telephone calls to the office from the patient's mother.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 102
Type of DevicePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2265683
Report Number1644487-2011-02283
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation OTHER CAREGIVERS
Type of Report Initial,Followup
Report Date 08/31/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/27/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2010
Device MODEL Number102
Device LOT Number200908
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/05/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/03/2008
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: 09/27/2011 Patient Sequence Number: 1
-
-