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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL UNK Back to Search Results
Event Date 10/01/2009
Event Type  Injury  
Event Description

It was reported by a neurologist that a vns pt was experiencing palpitations. The pt has been seizure free and had placed a magnet over her vns device for the past 1. 5 years. According to treating neurologist, the pt has long q-t interval but hasn't seen a cardiologist. The physician did not know if pt's cardiac symptoms have subsided since he just inherited the pt from another physician. Good faith attempts to obtain more info regarding pt's adverse event have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL UNK
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key2039448
Report Number1644487-2011-00685
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 03/01/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/31/2011
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? Yes
Date Manufacturer Received03/01/2011
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: 03/31/2011 Patient Sequence Number: 1
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