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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
Event Date 02/01/2012
Event Type  Injury  
Event Description

It was reported by a nurse that a vns patient experiences vns related asthma. The patient claimed to not have seen her vns physician since 2009 and was warned prior to implant that this could possibly be a side effect from therapy. At the moment, the patient is looking for another physician. Additional information was received from the previous treating nurse indicating the patient suffers from psychological problems. The respiratory problems referred to by the patient have been looked at by a lung specialist and many settings were tried out in order to accommodate the patient, but patient remained unhappy, claiming depression when generator was turned off and asthma when turned on.

 
Event Description

Moreover, additional information from the treating physician indicated the patient was psychologically unstable prior to vns. After vns was implanted, the patient would have periods of depression which nonetheless were higher than pre-vns baseline.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2467534
Report Number1644487-2012-00511
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/01/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/24/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2007
Device MODEL Number102
Device LOT Number012081
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received03/22/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2005
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: 02/24/2012 Patient Sequence Number: 1
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