• 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 01/25/2012
Event Type  Injury  
Event Description

Clinic notes were received for review in relation to this patient's generator being near end of battery life. In review it was noted that on (b)(6) 2013 "she reports 2 episodes a month, one episode is in the last week of the month, which is like an aura, which she describes as not being in control. " it was noted on (b)(6) 2012 that the patient reports episodes of thought disturbances, which she reports as a feeling of having a seizure. She says she hears that something may happen in her mind. This usually happens at the end of the month. She reports that she had a black out spell at the first of the week. A black out means that she loses consciousness, she recalls losing the consciousness, though doesn't recall anything else. She lives alone and these events are not witnessed. Good faith attempts have been made and no further information has been attained. Relationship of this black out spell to their vns is unknown. Unknown if part of the patient's usual seizure pattern.

 
Manufacturer Narrative

 
Manufacturer Narrative

Suspect medical device - implant date - corrected data: implant date corrected.

 
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 herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3052305
Report Number1644487-2013-00984
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/12/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/11/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2008
Device MODEL Number102
Device LOT Number015709
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/12/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/22/2006
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: 04/11/2013 Patient Sequence Number: 1
-
-