• 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 09/05/2007
Event Type  Malfunction  
Event Description

Reporter indicated the patient has experienced "life changing side effects" from the vns therapy system. The "patient reports a number of non-specific complaints including not feeling well, blood pressure fluctuation, intermittent chest pain, having been in the hospital on several occasions, including receiving a coronary stent. The patient also states the device has not helped his seizure disorder. " the patient elected to have the vns therapy system explanted. Good faith attempts are being made to obtain additional information, but have been unsuccessful to date.

 
Manufacturer Narrative

Device malfunction is suspected, but did not cause or contribute to a death.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
michael carroll
100 cyberonics blvd., ste 600
houston , TX 77058
2812287200
MDR Report Key959423
Report Number1644487-2007-02100
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/06/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/06/2007
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device EXPIRATION Date03/31/2007
Device MODEL Number102
Device LOT Number012850
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received11/06/2007
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/01/2005
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: 12/06/2007 Patient Sequence Number: 1
-
-