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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 08/15/2014
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that the patient was seen by the neurologist and it was determined that the cardiac event has no relation to vns.

 
Event Description

It was reported that the vns patient was diagnosed with heart disease. The patient¿s cardiologist stated that vns may be affecting the patient¿s heart. Attempts for additional relevant information have been unsuccessful to date.

 
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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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4085358
Report Number1644487-2014-02327
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Consumer,Health Professional,Company Representative,Distributor
Reporter Occupation Patient
Type of Report Initial,Followup,Followup
Report Date 08/15/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/12/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date03/31/2011
Device MODEL Number102
Device LOT Number2429
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received11/05/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/10/2009
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: 09/12/2014 Patient Sequence Number: 1
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