• 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 03/01/2012
Event Type  Malfunction  
Event Description

Reporter indicated that since she had intentionally lost weight approximately six months ago, her vns was causing muscle twitching and painful stimulation. The reporter currently does not feel the vns stimulation in her neck but at the clavicle, and reported that her depression has increased since the events began. A vns battery life estimate performed by the manufacturer resulted in approximately 3. 30 years remaining, indicating generator end of service is unlikely. Attempts for further information from the treating psychiatrist are in progress.

 
Manufacturer Narrative

(b)(4).

 
Event Description

Manufacturer follow up with the treating psychiatrist revealed the patient's vns is operating properly. The patient has not been seen since (b)(6) 2012 due to financial issues. The patient is on several medications for her depression. The patient's depression does fluctuate due to outside personal stressors, and the reported increased depression is not felt to be due to the vns. The vns has been helpful for the patient. The reporter also later indicated to the manufacturer that the vns was also felt to be helpful for her depression.

 
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 Key2763617
Report Number1644487-2012-02459
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/30/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/27/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2008
Device MODEL Number102
Device LOT Number016672
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received09/27/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2007
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-