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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Event Date 01/29/2016
Event Type  Death  
Manufacturer Narrative

 
Event Description

It was reported on (b)(6) 2016 that the patient died on (b)(6) 2016. The patient was implanted with vns on (b)(6) 2014. Attempts for additional information have been made but have been unsuccessful to date.

 
Event Description

Follow-up information from the physician indicated that the patient's cause of death was abdominal sepsis / renal insufficiency, not related to vns therapy.

 
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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 Key5499226
Report Number1644487-2016-00549
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup
Report Date 02/18/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/14/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2016
Device MODEL Number103
Device LOT Number202945
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/30/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/03/2014
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: 03/14/2016 Patient Sequence Number: 1
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