• 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 GENERATOR

  • 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 GENERATOR Back to Search Results
Model Number 103
Event Date 08/01/2012
Event Type  Injury  
Event Description

It was reported that the vns patient was making new "breathy or wheezy" noises that were different than normal. The patient was noted as having to go to the hospital in august due to increased seizures. The patient was noted as no longer experiencing seizures in the daytime. The patient used to experience 1-2 seizures per week in the daytime that are approximately 30 seconds in duration however now the patient experiences 5 seizures per night that are approximately 10 seconds in duration. Vns magnet activations are usually effective at stopping the patient's seizures. The patient was also noted as experiencing a change in vocalizations. The patient's vns was noted as now being near end of service. The patient has been referred for vns generator replacement. Attempts for additional information have been unsuccessful to date.

 
Manufacturer Narrative

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2832892
Report Number1644487-2012-03008
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 10/15/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/15/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/17/2011
Device MODEL Number103
Device LOT Number2497
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received10/15/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 11/15/2012 Patient Sequence Number: 1
-
-