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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Device Problem Insufficient Information
Event Date 05/28/2012
Event Type  Death  
Event Description

Confirmation was received from the physician¿s office that this the reported patient in supplemental report #1 was the patient who passed away.

 
Event Description

The company representative found information that may suggest the patient¿s device is sn (b)(4) which was tied to a patient implanted on (b)(6) 2007 and was treated by the same physician¿s office. Attempts for confirmation from the physician¿s office that this is the patient who passed away have been unsuccessful to date.

 
Manufacturer Narrative

 
Event Description

A nurse at the physician' office reported that a patient passed away approximately six months ago. She did not know the exact date or reason why. She indicated she had just recently found out. Attempts for additional information from the nurse and physician's office have been unsuccessful to date.

 
Event Description

This death information has been reviewed and with the available information has been determined to be possible sudep by the manufacturer¿s nurse as the cause of death is unknown with the available information. Obituary was found online which reported the patient passed away on (b)(6) 2012. Follow-up with the funeral home indicated that there were no records of the vns devices being explanted prior to burial.

 
Event Description

Cause of death information obtained from the (b)(6) was reviewed by the manufacturer which indicated that the patient's cause of death was respiratory failure. It was noted that the cause of death was pneumonitis due to food and vomit. There is no allegation or other information indicating that the death is related to vns.

 
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Brand NamePULSE GEN MODEL 102
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 Key3085402
Report Number1644487-2013-01199
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative,COMPANY REPRESENTATI
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/04/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/30/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2008
Device MODEL Number102
Device LOT Number016158
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/19/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/10/2006
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: 04/30/2013 Patient Sequence Number: 1
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