• 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 103 GENERATOR

  • 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 103 GENERATOR Back to Search Results
Model Number 103
Event Date 01/07/2015
Event Type  Death  
Event Description

It was reported that the patient was seen by the physician on (b)(6) 2015. The vns was working fine and the physician decreased the off time from 1. 8 min to 1. 1 min and no other settings were changed. The patient stayed with a family member in the waiting room for an hour and tolerated the changed to the settings well. The patient went home and a few hours later, family member stated that they found him in the bathroom unresponsive. Exact cause of death is unknown; however, the physician stated she did not feel that the cause of death was due to vns. The patient underwent an autopsy but there is no ruling yet on the cause of death. It was noted that the vns device was explanted but the medical examiner¿s office keeps the device for two years. The physician later reported that the patient had concurrent illnesses of cognitive delay and psychosis. She stated it was unknown what the cause of death was and the relationship of the patient¿s death to vns.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4486693
Report Number1644487-2015-03756
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 01/12/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/05/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2014
Device MODEL Number103
Device LOT Number202183
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/12/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/25/2012
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: 02/05/2015 Patient Sequence Number: 1
-
-