• 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 104

  • 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 104 Back to Search Results
Model Number 104
Event Date 07/27/2011
Event Type  Death  
Event Description

Reporter indicated a vns pt had died due to an unk reason. The pt had gone to the dentist and returned to her rehabilitation home. The staff found the pt ten minutes after his return lying on the floor. Defibrillation was considered but not performed peer the physician at the scene. The pt does have a history of pulmonary embolisms, but it is known if this was a factor in the death. It is unk if an autopsy was performed. Attempts for further info and the death certificate are in progress.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 104
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
suite 600
houston , TX 77058
2812287200
MDR Report Key2234228
Report Number1644487-2011-01964
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/28/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/23/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2011
Device MODEL Number104
Device LOT Number201210
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/28/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2009
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: 08/23/2011 Patient Sequence Number: 1
-
-