• 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 102MUZ

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 

CYBERONICS, INC. PULSE GEN MODEL 102 MUZ   Back to Search Results
Model Number 102
Event Date 01/01/2006
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Reporter indicated that he started experiencing manic episodes approx 1 month following the implant of the vns therapy system. Reporter stated he was then prescribed lithium by his dr, and that the mania subsided with the daily use of this medication.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 102
Type of DeviceMUZ
Manufacturer (Section F)
CYBERONICS, INC.
houston TX 77058
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
donnie welty, rn, bsn
100 cyberonics blvd.
ste. 600
houston , TX 77058
(281) 228 -7200
Device Event Key823699
MDR Report Key836404
Event Key799295
Report Number1644487-2007-00160
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Consumer
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 02/07/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/11/2007
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date06/30/2007
Device MODEL Number102
Device LOT Number013620
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/07/2007
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2005
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device? No Answer Provided
Type of Device Usage Initial

-
-