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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 04/29/2010
Event Type  Death  
Event Description

It was reported that a vns pt passed away. Previously, the pt had reported an increase in depression and was looking for a vns physician as it had been several years since the last time he had his vns device checked. The increased depression was reported in mdr 1644487-2010-00388. The pt made an appointment to see a physician; however, the pt did not make the appointment nor was the appointment rescheduled. Good faith attempts to obtain additional information surrounding the pt's death are currently being made.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key2032662
Report Number1644487-2011-00647
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 02/26/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/28/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/29/2008
Device MODEL Number102
Device LOT Number015484
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received02/26/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2006
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: 03/28/2011 Patient Sequence Number: 1
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