• 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 07/28/2010
Event Type  Injury  
Event Description

Initial reporter indicated that they had a pt who was admitted to the hospital for increased depression. It was reported that their depression was likely over their pre vns rate, but relationship to their vns is unk. No diagnostics were performed. The pt had her device temporarily deactivated in order to received ect treatment, which she has previously responded to. It is unk if the pt had any medication change or life event prior to the onset of their increased depression. Good faith attempts thus far have been unsuccessful attainting any further details.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1822469
Report Number1644487-2010-01956
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 07/28/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/26/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2008
Device MODEL Number102
Device LOT Number015790
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/28/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2006
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: 08/26/2010 Patient Sequence Number: 1
-
-