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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS PULSE GEN MODEL UNK GENERATOR

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CYBERONICS PULSE GEN MODEL UNK GENERATOR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury  
Event Description

It was reported that this patient almost died after having the vns implanted, and spent almost an entire year in the hospital due to the vns, and was put on life support. It was stated that the patient is now permanently disabled because of it. The patient had never before been treated for depression, and the patient had the device implanted to treat her seizures, but not only did the device make her seizures become so bad they almost killed her, but it caused her to become severely depressed, which is something she had never been diagnosed with before. It was stated that the family has suffered great tragedy because of the device. No other relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL UNK
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS
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 Key7472454
Report Number1644487-2018-00692
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type OTHER
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial
Report Date 04/30/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/30/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/05/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 04/30/2018 Patient Sequence Number: 1
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