• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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 06/27/2008
Event Type  Death   Patient Outcome  Death
Event Description

It was reported that the vns epilepsy pt passed away. The physician informed the mfr that the cause of death was sudep. Treating physician reported that the pt's generator was inadvertently programmed off and determined that the pt was without vns therapy for approx 5 months (refer to mfg report # 1644487-2008-01741). Pt's device was then programmed back on to 0. 5ma. The pt passed away the following day. An autopsy was performed. The treating physician reported that death was not related to vns therapy. Pt's generator and lead were explanted after death and returned to the mfr. Analysis on the returned generator has been completed. There were no performance or any adverse conditions found with the pulse generator during lab analysis. Prod analysis on the explanted lead is pending. Good faith attempts to obtain autopsy results and programming history have been unsuccessful to date.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 102
Manufacturer (Section F)
CYBERONICS, INC.
houston TX 77058
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
michael carroll
100 cyberonics blvd.
ste. 600
houston , TX 77058
(281) 228 -7200
Device Event Key1070718
MDR Report Key1091663
Event Key1049194
Report Number1644487-2008-01735
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 07/03/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/31/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date09/30/2007
Device MODEL Number102
Device LOT Number014188
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer07/11/2008
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received07/03/2008
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/01/2005
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

-
-